Wellcome - Clinical trials for infectious diseases

Wellcome - Clinical trials for infectious diseases is sponsored by Wellcome Trust. This opportunity supports mission-aligned projects and measurable outcomes.

### This scheme is now closed Lead applicant career stage:Administering organisation location: Low- or middle-income country in Africa, South Asia or South-East Asia (apart from mainland China) Between £1,000,000 - £8,000,000 per award. We invite applications for any amount within this range.

The pharmaceutical intervention (vaccine or therapeutic) must focus on one of the following disease areas: * mycobacterial infections (tuberculosis, leprosy or infections with non-tuberculous mycobacteria) * bacterial infections (sexually transmitted infections, lower respiratory tract infections or bloodstream infections) * invasive fungal infections * dengue, leishmaniasis or schistosomiasis ## Upcoming application stage Calculating next key date… Application process timeline You can apply to this call if your team: * Includes a lead applicant and at least one coapplicant based at an organisation in Africa, South Asia or South‑East Asia, both of whom intend to remain resident in that country for the duration of the award.

See a full list of countries that are eligible to apply. * Is an appropriate size for the proposed project. Teams must not exceed eight applicants (lead applicant and seven coapplicants).

There is no limit on the number of collaborators. * Has at least 50 percent of applicants based in Africa, South Asia or South-East Asia. Teams may include coapplicants based at eligible organisations in other parts of the world.

We encourage applications from teams that: * are diverse and transdisciplinary covering multiple areas of expertise * include researchers at any stage of their career * Have the expertise and experience to design, plan and conduct clinical trials of infectious disease interventions.

* Include the scientific and analytical skills to manage, interpret and analyse trial data, and to generate evidence that could inform policy, practice or guidelines. * Have experience of building partnerships and networks. * Include public health stakeholders and policymakers relevant to the proposed research.

Their involvement can either be as a coapplicant or collaborator on the grant. Public health stakeholders or policymakers who are collaborators must provide a letter of support. * Demonstrate experience of collaborating or engaging with public health stakeholders, policymakers and communities most affected, such as community leaders, civil society and community organisations in the design and implementation of the research.

This includes communicating research outputs such as evidence and data in a way that is useful and timely for public health decision-making. * Actively foster a diverse, inclusive and supportive research environment. * Be a mid-career or established researcher.

If the lead applicant is a mid-career researcher, we strongly encourage including an established researcher as a coapplicant to provide intellectual, personal and career development support and mentorship. * Be based at an organisation in Africa, South Asia or South-East Asia(except mainland China) and intend to remain resident in that country for the duration of the award.

* Have the experience needed to design, plan and conduct clinical trials. * Have the scientific and analytical skills to manage, interpret and analyse trial data. * Have the experience needed to lead a collaborative, large scale research project and the necessary support structures in place.

* Only be a lead applicant on one application for this funding call. They may be a coapplicant on one additional application. The applications should be for different projects.

If both projects receive funding, the applicant must be able to demonstrate that they can dedicate enough time and resources to both projects. * Have a permanent, open-ended or long-term rolling contract – or the guarantee of one – for the duration of the award. The contract should not be conditional on receiving this award.

Lead applicants with less than three years remaining on their contract at the point of application must have secured their next position at an eligible organisation and provide a letter of support from that organisation. * Have a salary paid by their host organisation for the duration of the award.

Applicants who are based in a low- or middle-income country can ask for a contribution to their salary if they hold a permanent, open-ended or long-term rolling contract and rely on external grant funding for their salary. * Actively promote a diverse, inclusive and supportive environment within their team and across their organisation. * Can be based anywhere in the world except mainland China.

We expect at least 50 percent of coapplicants to be based at organisations in Africa, South Asia or South-East Asia, with the intention to remain resident in that country for the duration of the award. * Can be based at the same or different organisations as other applicants, including in different countries. * Can be at any career stage and come from any relevant discipline.

* Must be essential for the delivery of the project and make a significant contribution, for example designing an aspect of the research, writing the application, leading on a specific work package or aim, or being responsible for research or policy uptake. * Can be involved on a maximum of two applications for this funding call. The applications should be for different projects.

If both projects receive funding, the applicant must be able to demonstrate that they can dedicate enough time and resources to both projects. * Do not need to have a permanent, open-ended or long-term rolling contract. * Can be based at a commercial organisation.

* Can be based at a multilateral organisation. Please**contact us**to discuss further if this applies to you. When contacting please confirm whether your organisation can accept out standard grant conditions.

Proposals must meet all funding call requirements. Collaborators are distinct from coapplicants. Collaborators support the delivery of the project but don't lead on a specific component of the research.

For example, collaborators could support by: * providing access to tools or resources such as datasets or clinical records * providing access to organisations led by or working in collaboration with lived experience experts * providing expertise on working in different countries * sharing subject-specific knowledge and guidance, for example, expertise on statistical analysis or measurement of specific variables Collaborators do not have to meet eligibility requirements, and they are not required to give a minimum research time commitment.

Collaborators cannot receive a salary or compensation for the time spent on the proposed project. You can request costs to cover their expenses, for example for their grant-related travel and the costs associated with providing the agreed input into the research, including the materials and consumables involved. These should be costs directly related to the research.

If one of your collaborators is a public health stakeholder or policymaker, a letter of support must be provided. ### If you’ve spent time away from research You can apply for this award if you have spent time away from research (for example, for a career break, parental leave or long-term sick leave). We will take this into consideration during the review of your application.

Lead and coapplicants can be working part-time. Their part-time work should be compatible with delivering the project successfully.

You should not apply for this call if: * you intend to carry out activities which involve the transfer of funds into mainland China * you are a lead applicant based at an organisation outside of Africa, South Asia or South-East Asia * you are an individual without at least one coapplicant * you are a lead applicant based at a commercial or multilateral organisation * you cannot demonstrate the ability to dedicate enough time and resources to the project, if funded * you are a lead applicant on another application for this award * you are listed as a coapplicant on more than two applications for this award * you are a lead applicant on an application for our Infectious Disease Clinical Trial Development Award * your proposal does not focus on one of the disease areas specified in the list below: * mycobacterial infections (tuberculosis, leprosy or infections with non-tuberculous mycobacteria) * bacterial infections (sexually transmitted infections, lower respiratory tract infections or bloodstream infections) * invasive fungal infections * dengue, leishmaniasis or schistosomiasis ## Is your organisation right for this call?

The administering organisation is where the lead applicant is based. It is the organisation responsible for submitting your final application to Wellcome and managing the grant if it is awarded. ### Where your administering organisation is based The administering organisation should be based in Africa, South Asia or South-East Asia (apart from mainland China).

See a full list of countries that are eligible to apply. The administering organisation can be a: * higher education institution * healthcare organisation * not-for-profit or non-governmental research organisation This funding call is open to Wellcome’s major international programme partnerships in Africa and Asia (KWTRP, AHRI, MLW, MORU and OUCRU).

Commercial organisations are not eligible to apply as administering organisations for this call. However, coapplicants and collaborators can be based at commercial organisations. Multilateral organisations are not eligible to apply as administering organisations for this call.

However, coapplicants and collaborators can be based at multilateral organisations. Please**contact us**to discuss further if this applies to you. Proposals must meet all funding call requirements.

### Collaboration agreements If the application involves a collaboration or partnership between multiple organisations, the partners must enter into a suitable collaboration agreement, including provisions that cover: * division of grant activities between the parties * management and distribution of the grant funding * access to background intellectual property * ownership of foreground intellectual property * arrangements for the protection, management and exploitation of foreground intellectual property The lead applicant’s administering organisation is required under our grant conditions to own all the foreground intellectual property arising from the project and to take the lead in any commercialisation activity.

For guidance, read Wellcome’s intellectual property policy. ### Your research environment Wellcome believes that a diversity of people and expertise leads to richer understanding and more impactful discoveries. Excellent research happens in environments where people from all backgrounds are treated with respect and are supported and enabled to thrive.

Our definition of a research environment is not limited to the quality of the infrastructure but also considers the culture and behaviours that create excellent research practice. This includes research that is inclusive in design and practice, ethical and engaged with relevant community stakeholders, as well as open and transparent. Read guidance on how to talk about research environment in your application.

## Is your research right for this call? Wellcome’s Infectious Disease strategy focuses on minimising the impact of infectious diseases on the most affected communities. Whilst new vaccines and treatments may have regulatory approval, their full impact is often limited by a lack of data on their optimal use, including the target population, dosage, range of indications, combinations, and evaluation in real-world settings.

This can result in interventions failing to be adopted into guidelines or by policymakers. This funding call aims to support high-quality randomised controlled trials that optimise licensed pharmaceutical interventions.

The evidence generated should result in changes to policy, practice or guidelines at a national, regional or global level, and lead to near-term impact in communities most affected by infectious diseases in low- and middle-income countries.

If you have an innovative idea for a randomised controlled trial proposal, but need to build your team, develop your clinical trial protocol or generate pilot data, you can apply to our Infectious Disease Clinical Trial Development Award. ### What your research proposal must include Your research proposal must include: **1.

The intervention and disease area of focus** * The pharmaceutical intervention (vaccine or therapeutic) should focus on one of the following disease areas: * mycobacterial infections (tuberculosis, leprosy or infections with non-tuberculous mycobacteria) * bacterial infections (sexually transmitted infections, lower respiratory tract infections or bloodstream infections) * invasive fungal infections * dengue, leishmaniasis or schistosomiasis **2.

A detailed plan of work** * An overview of the importance and relevance of the topic and the current evidence base, which policy, practice or guideline it is seeking to change and how a clinical trial will generate the required evidence for that change. * A clear outline of the work that will be conducted, including risks and mitigations.

* The type of clinical trial, for example repurposing of current licensed interventions, pragmatic trials evaluating effectiveness of interventions in real-world settings, Phase 3 type, Phase 4 or post-marketing studies. * Details of your clinical trial in the relevant sections of the application form, including appropriate consideration of safety aspects.

In some cases, we acknowledge that a controlled trial does not have to be randomised. * A description of who will be most impacted by your research and its outputs. * Details of the populations or groups included in the data collection, analysis and reporting.

Trials conducted in underserved populations are encouraged. * Consideration of cost-effectiveness and health economics of the intervention in low- and middle-income settings. * A clear description of how the award will meet the requirements set out in theWHO guidance for best practices for clinical trials.

* A Gantt chart and justification for the timeline for the proposed work. **3. Country context and relevance** * Justification for the choice of country or countries,including a plan for conducting laboratory research, enhancing laboratory capability, training and data analysis, with appropriate sensitivities about how the findings may impact different affected groups.

* Details of the relevance of the proposed research inlow- and middle-income countries. * A clear plan for how your proposal will build clinical research expertise and capacity in the specified African, South Asian or South-East Asian locations. **4.

Data management and governance** * A description of your approach to data management, integration and/or sharing of the different data types detailed in your work plan within the ‘Outputs management and sharing’ section of the application form. You must include how you plan to share data with relevant stakeholders.

* For multi-country projects, a data management plan for international data transfers or accessibility, security and procedures for associated regulatory requirements and/or permissions, within the ‘Outputs management and sharing’ section of the application form. Learn more about our**data, software and materials management and sharing policy****. ** **5.

Stakeholder Engagement** * A description of how you will embed anduse an engaged research approach and work collaboratively with public health stakeholders, policymakers and communities most affected (such as community leaders, civil society and community organisations).

* A description of your dissemination plan to ensure that your research is shared with relevant stakeholders, including communities you work with throughout the project and those who influence national, regional or global decision making. * Consideration of how you will further develop the research outputs and make them available to the communities involved with minimum barriers to access.

### What your research proposal can include Your research proposal can include: * research based in more than one location or country * consideration of social science elements ### What your research proposal must not include Research that isn’t right for this call: * Phase 1, Phase 2, Phase 3 product development clinical trials of unlicensed interventions.

* Controlled human infection, observational, modelling, implementation research or community engagement studies. * Studies on non-pharmaceutical interventions.

* Studies that do not focus on at least one of the following disease areas: * mycobacterial infections (tuberculosis, leprosy or infections with non-tuberculous mycobacteria) * bacterial infections (sexually transmitted infections, lower respiratory tract infections or bloodstream infections) * invasive fungal infections * dengue, leishmaniasis or schistosomiasis * Studies that do not consider equitable access, including acceptability, affordability and availability of the intervention post-trial should the trial show a definitive result.

SeeWellcome’s approach to equitable access to healthcare interventions. * Proposals exclusively being addressed by researchers based in institutions in a high-income setting or in Latin America and the Caribbean. * Proposals that do not consider how to engage public health stakeholders, policymakers and communities most affected by infectious disease.

* Proposals that include activities which involve the transfer of grant funds into mainland China. ## How applications are assessed Applications will be assessed by an external committee of experts who will review eligible and in-scope proposals and make funding recommendations to Wellcome.

### Essential criteria and weightings **The research proposal (50% weighting)** * Strong justification for the: * pharmaceutical intervention (vaccine or therapeutic) including current existing evidence * type of clinical trial being conducted * location(s)or site selection where the research is to be conducted * The importance of the policy, practice or guideline that you are seeking to change and how a clinical trial will generate the required evidence for that change.

* The potential impact that this award would have in low- and middle-income countries. * Clear description of the proposed plan of work and key deliverables with appropriate and justified timelines, including ethical and regulatory timelines. * The suitability, quality and feasibility of the study design, methods and sample size to ensure delivery of an informative study.

* Appropriate recruitment and retention plans. * Appropriate justification for the inclusion/exclusion of underserved populations. * Clearly identified risks and mitigation.

* A clear description of how you will capture, monitor and ensure data quality across all sites (particularly if it is a multicentre trial). * A clear description of your dissemination plans in the different stages of the study to ensure transparency and information sharing. * A clear description of how the application will help build capacity and experience in the specified locations.

**The team’s skills and experience (25% weighting):** * the experience needed to design, plan and conduct clinical trials * the scientific and analytical skills to manage, interpret and analyse trial data * the experience needed to lead and manage a collaborative, large scale research project * Is transdisciplinary and includes the necessary expertise, skills and experience to deliver the proposed work in disease-affected settings.

* Has appropriate management plans including a clear description of how the team will work collaboratively to deliver the proposed research. * Has an appropriate governance structure in place that will support decision making and management of the research project. * Demonstrates a strong commitment to equity, diversity and inclusion.

For example, your approach to recruiting a diverse team and how you will promote inclusion of members in the research and outputs.

**Engagement with stakeholders (25% weighting):** * a clear description of how the team will embed an engaged research approach through the lifecycle of their research proposal with relevant stakeholders, including with public health stakeholders, policymakers and communities most affected (such as community leaders, civil society and community organisations) * a clear description of the team’s approach to equitable partnerships and how it is responsive to the needs and interests of the populations that the project is intended to serve * a clear dissemination plan for engaging key stakeholders and appropriate budget allocation ## Research costs we will cover You must contribute at least 10% of your research time to the award in order to claim a contribution to your salary.

##### Lead applicants based outside of the UK or Republic of Ireland You can ask for a contribution to your salary if you work for a: * higher education institute * healthcare organisation * non-governmental organisation If you work for a higher education institute, research institute, or healthcare organisation, we will only pay your salary if you hold a permanent, open-ended or long-term rolling contract that states that you must get your salary from external grant funding.

Your administering organisation must confirm: * that you must get salary recovery from external grant funding * they will guarantee to provide salary support, including any salary not covered by Wellcome, if you cannot get it from other sources for the period of time that you will be working on the grant In all cases, the amount we pay will be proportionate to the time you contribute to the award.

For example, if you contribute 30% of your time to the award we will fund 30% of your salary. Coapplicants must contribute at least 10% of their research time to the award in order to claim a contribution to their salary. ##### Coapplicants employed by higher education institutes, research institutes or healthcare organisations 1.

###### Coapplicants with permanent, open-ended or long-term rolling contracts Coapplicants with these contract types can ask for a contribution to their salary if their employment contract states that they must get their salary from external grant funding. The amount we pay will be proportionate to the time they contribute to the award, for example if they contribute 30% of their time to the award we will fund 30% of their salary.

The coapplicant’s employing organisation must confirm: * that they must get salary recovery from external grant funding * they will guarantee to provide salary support, including any salary costs not covered by Wellcome, for the period of time that the person will be working on the grant 2.

###### Coapplicants who don’t have permanent, open ended or long-term rolling contracts Coapplicants without a permanent, open ended or long-term rolling contract can request salary depending on the amount of their time they will spend on the grant: * Less than 80% of coapplicant’s time on the grant: they can request salary proportionate to the time they will spend on the grant (minimum 10% research time).

Their organisation must guarantee space and salary support if they cannot get it from other sources for the period of time they are working on the grant. Their post cannot be dependent on the application being successful. * 80% or more of coapplicant’s time on the grant: they can ask for their full salary.

Their organisation does not have to guarantee salary support if salary cannot be obtained from other sources for the period of time they are working on the grant. The post can be dependent on the application being successful.

* If the coapplicants are employed on the award as research assistants and they are to spend 100% of their time on the award, their post does not need to be underwritten by the administering organisation and can be dependent on the application being successful. Alternatively, coapplicants may get their salary through employment on another grant.

##### Coapplicants employed by charities, social enterprises, non-governmental organisations or commercial organisations Coapplicants can ask for salary if they are employed by these organisations. Coapplicants must contribute at least 10% of their research time to the award. The amount we pay will be proportionate to the time they will contribute to the award.

Their employment contract does not need to state that they must get their salary from external grant funding. #### Staff working on your programme We will cover the salary costs of all staff, full or part-time, who will work on your grant.

Staff members may include: * research assistants or technicians employed on your grant * experts with lived experience * specialist service staff and technical experts, for example in environmental sustainability, data analysis, fieldwork and clinical studies * project manager, if you have multiple applicants on your programme * support if you or a member of staff employed on your grant is disabled or has a long-term health condition Humanities and social science researchers can ask for funds for research or teaching replacement to cover the cost of a temporary replacement lecturer.

They must retain at least a 10% commitment to teaching.

* can cover up to 33% FTE of your contracted time * are usually for a person at a more junior level than the postholder * can be spread across the full period of the grant Researchers who already get buyout costs from another grant (funded by Wellcome or elsewhere) can ask us for this cost, but only for the period of time on the award when they won't receive buyout costs from another grant.

Researchers must provide a letter from their employing organisation, confirming that their contract includes a teaching commitment. They should include this in the grant application. **PhD/Research Masters fees** We do not provide studentships on this award.

But if applicants employ research staff, including technicians, on the grant they can ask for the costs to cover their PhD/Research Masters fees. Each applicant can ask for fees for up to two research staff in total on the grant, to a maximum of eight per team. Research staff should be hired to undertake specific research activities on the grant and we will cover the fees for their PhD/Research Masters studies.

Early-career applicants (up to and including holders of early-career fellowships) may not supervise a PhD student alone but can be a co-supervisor with a mid-career or established colleague. If fees are not requested at the application stage, grant funds cannot be repurposed for them during the award. Research staff should be defined as staff members and incur a lower fee than the student rate.

Where organisations do not have a staff rate, they may request fees at the home student rate. If no other rate is available, they may request the international student rate. Staff salaries should be appropriate to skills, responsibilities and expertise.

Organisations should use their salary scales to calculate these costs, which should include: * employer’s contributions, including any statutory obligations (for example, National Insurance contributions if you’re based in the UK) and pension scheme costs * Apprentice Levy charges for UK-based salaries * any incremental progression up the salary scale * locally recognised allowances such as London allowance You should allow for salary pay awards during Year 1.

If the pay award is not yet known, applicants should use the International Monetary Fund inflation rate, selecting the ‘inflation, average consumer price’ option as indicator. From Year 2 onwards, you should use your organisation’s current pay rates. We’ll provide a separate inflation allowance for salary inflation costs.

Read about the responsibilities of grantholders and organisations we fund. If you have named people on your grant whose salaries will be funded by Wellcome, you can ask for visa or work permit costs to help them take up their posts at the host organisation.

You can also ask for: * visa costs for the person's partner and dependent children * essential associated costs, such as travel to attend appointments at a visa application centre or embassy, and essential English language tests * Immigration Health Surcharge costs for the person, their partner and dependent children if they will be in the UK for six months or more.

If you or a member of staff working on your grant is disabled or has a long-term health condition, you can ask for adjustment support to help you carry out your project.

Costs can include, but are not limited to: * additional costs for staff to help with day-to-day activities related to your project * assistive technology to help use computers, research equipment or materials – for example, text to audio software * care costs for assistance animals if you need to travel. We will not pay for capital or building costs, such as access ramps.

You can ask for these costs if your government and/or employer: * does not cover any of the costs * only covers some of the costs (if they do, we will only meet the shortfall). The costs we provide must not replace the support you may get from the government or your organisation, who are responsible for providing these costs. If you don't know what these costs are now, you canask for them after we've awarded your grant.

We will pay for the materials and consumables you need to carry out your project, including: * laboratory chemicals and materials (for example reagents, isotopes, peptides, enzymes, antibodies, gases, proteins, cell/tissue/bacterial culture, plasticware and glassware) * project-specific personal protective equipment (PPE) that is above the standard expected for the setting * printing associated with fieldwork and empirical research * associated charges for shipping, delivery and freight.

We will provide funds if you need to outsource specialised elements of the project to organisations that are not already involved as applicants or collaborators, on a fee-for-service basis.

This work can include: * synthesising compounds or reagents * building medical devices * preclinical studies, such as toxicology or pharmacology studies * undertaking large scale data analysis Where multiple Contract Research Organisations are involved in a project, use a separate line item to request costs relating to each one.

You can ask for the cost of access to shared equipment, facilities or services if they’re essential to your project.

These may include materials and consumables, plus a proportion of: * maintenance and service contracts * staff time costs for dedicated technical staff employed to operate the equipment or facility We don’t cover the costs of: * depreciation or insurance * other staff, for example, contributions towards departmental technical, administrative and management staff time We do cover these costs if related to animal housing facilities.

If the facilities or equipment were paid for by a Wellcome grant, you can only ask for access charges if: * any support for running costs and maintenance contracts has ended You can ask for the equipment you need to carry out your project where: * it is not available at your administering organisation or through collaborations, and * you will be the main user, with priority access to it.

At least 50% of the use must be for Wellcome-funded activities. This can include small multi-use pieces of equipment such as desktop microscopes or shakers. Costs may include purchase, delivery, installation, maintenance and training, where necessary.

You can purchase second-hand equipment if it is more environmentally sustainable to do so.

We will cover VAT and import duties if: * the usual UK exemptions on equipment used for medical research don’t apply * you’re applying from a non-UK organisation, and you can show these costs can’t be recovered #### Equipment maintenance We will cover maintenance costs for equipment that is: * funded by us or another source * essential to the proposed project * five years old, or will become five years old during the lifetime of the grant * cost effective and environmentally sustainable to keep maintaining it Equipment maintenance can be requested for small pieces of equipment with multiple users if at least 50% of the use is for