Clinical Trial Protocol Registry and Library
Design, Analyze, Communicate: Working together to improve clinical study outcomes.
Focusing on research Protocols where the trial sites were located in low- and middle-income countries, this resource includes three ways to access the Protocol Library:
- A table of all of the clinical trial protocols included in the Protocol Library
- A downloadable Excel registry list of all the clinical trial protocols included in the Protocol Library
- The Protocol Library sorted into disease area folders to allow direct access to relevant protocols
Clinical Trial Protocol Registry Table
Use this table to filter the Protocol Library to access specific protocols.
Filter the resources using the dropdown menus. Select a column heading to sort. Click or tap on a row to view the full record
First Principal Investigator | Protocol Title | Disease/Disease Area | Region of Study |
Not listed |
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially with Adacel® in Healthy Subjects Aged 9 to 60 Years in the PhilippinesLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaDengue Sub AreaVAC Site CountriesPhilippines Source of Protocolclinicaltrials.gov Approximate Page Count102 Date of Scientific Journal Publication9/1/2021 Scientific Journal Publicationhttps://journals.lww.com/pidj/fulltext/2021/09000/immunogenicity_and_safety_of_a_tetravalent_dengue.16.aspx |
Dengue | Asia |
Nahid, Payam |
Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trialLink to ProtocolFirst Principal InvestigatorNahid, Payam Disease/Disease AreaTuberculosis Site CountriesMulti Source of Protocolclinicaltrials.gov Approximate Page Count246 Date of Scientific Journal Publication9/10/2022 Scientific Journal Publicationhttps://pmc.ncbi.nlm.nih.gov/articles/PMC9890454/ |
Tuberculosis | Multi |
Dorsey, Grant |
Prevention of Malaria in HIV-uninfected Pregnant Women and InfantsLink to ProtocolFirst Principal InvestigatorDorsey, Grant Disease/Disease AreaMalaria Site CountriesUganda Source of Protocolclinicaltrials.gov Approximate Page Count100 Date of Scientific Journal Publication4/6/2019 Scientific Journal Publicationhttps://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32224-4/fulltext |
Malaria | Africa |
Zaman, Khalequ |
Immunogenicity of novel monovalent oral poliovirus vaccine type 2 (nOPV2) with and without bivalent OPVLink to ProtocolFirst Principal InvestigatorZaman, Khalequ Disease/Disease AreaPolio Site CountriesBangladesh Source of Protocolclinicaltrials.gov Approximate Page Count130 Date of Scientific Journal Publication9/23/2023 Scientific Journal Publicationhttps://pmc.ncbi.nlm.nih.gov/articles/PMC10503264/ |
Polio | Asia |
Baeten, Jared |
A Phase 3B Open-Label Follow-on Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in WomenLink to ProtocolFirst Principal InvestigatorBaeten, Jared Disease/Disease AreaHIV Site CountriesMulti Source of Protocolclinicaltrials.gov Approximate Page Count284 Date of Scientific Journal Publication2/8/2021 Scientific Journal Publicationhttps://linkinghub.elsevier.com/retrieve/pii/S2352-3018(20)30304-0 |
HIV | Africa |
Not listed |
hase III randomized, open, controlled study to the immune response to the hepatitis B candidate vaccine, when administered as primary vaccination integrated into an Saharan Africa. Phase III randomized, open, controlled study to evaluate the immune response to the hepatitis B antigen of the RTS,S/AS01E candidate vaccine, when administered as primary vaccination integrated into an EPI regimen to infants living in sub-Saharan AfricaLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaMalaria Sub AreaVAC Site CountriesMulti Source of Protocolclinicaltrials.gov Approximate Page Count120 Date of Scientific Journal Publication4/13/2018 Scientific Journal Publicationhttps://www.tandfonline.com/doi/full/10.1080/21645515.2018.1442996 |
Malaria | Africa |
Not listed |
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially with Cervarix® in Healthy Female Subjects Aged 9 to 14 Years in MexicoLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaHPV Sub AreaVAC Site CountriesMexico Source of Protocolclinicaltrials.gov Approximate Page Count100 Date of Scientific Journal Publication6/8/2021 Scientific Journal Publicationhttps://www.sciencedirect.com/science/article/pii/S0264410X21005466?via%3Dihub |
HPV | North America |
Impaact |
Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their InfantsLink to ProtocolFirst Principal InvestigatorImpaact Disease/Disease AreaHIV Site CountriesMulti Source of Protocolclinicaltrials.gov Approximate Page Count163 Date of Scientific Journal Publication4/3/2021 Scientific Journal Publicationhttps://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00314-7/abstract |
HIV | Multi |
Naidoo, Anushka |
A phase 2b study to evaluate the efficacy, safety and pharmacokinetics of a combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate for treatment of HIV-1 infection in patients with drug-susceptible tuberculosis on a Rifampicin-based treatment regimenLink to ProtocolFirst Principal InvestigatorNaidoo, Anushka Disease/Disease AreaTB Site CountriesSouth Africa Source of Protocolclinicaltrials.gov Approximate Page Count50 Date of Scientific Journal Publication11/10/2022 Scientific Journal Publicationhttps://bmjopen.bmj.com/content/12/11/e067765.long |
TB | Africa |
Not listed |
Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral PreExposure Prophylaxis for Primary HIV Prevention during Pregnancy and Postpartum in Adolescents and Young Women and their InfantsLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaHIV Site CountriesMulti Source of Protocolclinicaltrials.gov Approximate Page Count173 Date of Scientific Journal Publication12/20/2020 Scientific Journal Publicationhttps://academic.oup.com/cid/article/73/7/e1893/6042339?login=false |
HIV | Africa |
Opoku, Nicholas |
Safety and efficacy of triple drug therapy for individuals infectied with Onchocerca volvulusLink to ProtocolFirst Principal InvestigatorOpoku, Nicholas Disease/Disease AreaOnchocerca volvulus Site CountriesGhana, Liberia, and the Democratic Republic of the Congo Source of Protocolclinicaltrials.gov Approximate Page Count49 Date of Scientific Journal Publication1/18/2018 Scientific Journal Publicationhttps://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32844-1/fulltext |
Onchocerca volvulus | Africa |
Not listed |
An Open-label, Randomized, Controlled, Single Centre, Phase IIb Study to Assess the Immunogenicity, Reactogenicity and Safety of Three Live Oral Rotavirus Vaccines, ROTAVAC®, ROTAVAC 5CM and Rotarix® in Healthy Zambian InfantsLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaRotavirus Sub AreaVAC Site CountriesZambia Source of Protocolclinicaltrials.gov Approximate Page Count100 Date of Scientific Journal Publication5/1/2016 Scientific Journal Publicationhttps://academic.oup.com/cid/article/62/suppl_2/S175/2478858 |
Rotavirus | Africa |
Not listed |
A multicenter, randomized, double-blind, placebocontrolled phase 2b efficacy study of a heterologous prime/boost vaccine regimen of Ad26.Mos4.HIV and aluminum phosphateadjuvanted Clade C gp140 in preventing HIV-1 infection in women in sub-Saharan AfricaLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaHIV Sub AreaVAC Site CountriesMulti Source of Protocolclinicaltrials.gov Approximate Page Count146 Date of Scientific Journal Publication7/21/2018 Scientific Journal Publicationhttps://pmc.ncbi.nlm.nih.gov/articles/PMC6192527/ |
HIV | Africa |
Not listed |
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially with Gardasil® in Healthy Subjects Aged 9 to 13 Years in MalaysiaLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaDengue Sub AreaVAC Site CountriesMalaysia Source of Protocolclinicaltrials.gov Approximate Page Count100 Date of Scientific Journal Publication8/1/2021 Scientific Journal Publicationhttps://journals.lww.com/pidj/fulltext/2021/08000/immunogenicity_and_safety_of_a_tetravalent_dengue.19.aspx |
Dengue | Asia |
Oldenburg, Catherine |
Gut and Azithromycin Mechanisms in Infants and Neonates in Burkina FasoLink to ProtocolFirst Principal InvestigatorOldenburg, Catherine Disease/Disease AreaMalaria Site CountriesBurkina Faso Source of Protocolclinicaltrials.gov Approximate Page Count53 Date of Scientific Journal Publication3/25/2022 Scientific Journal Publicationhttps://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-022-07296-4 |
Malaria | Africa |
Not listed |
A Phase II, open label, single arm trial to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of rilpivirine (TMC278) in antiretroviral-naïve HIV-1 infected adolescents and children aged ≥6 to <18 yearsLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaHIV Site CountriesMulti Source of Protocolclinicaltrials.gov Approximate Page Count234 Date of Scientific Journal Publication12/6/2021 Scientific Journal Publicationhttps://pmc.ncbi.nlm.nih.gov/articles/PMC8846324/ |
HIV | Multi |
Not listed |
Efficacy and Safety of Fexinidazole in Children at Least 6 Years of Age and Weighing Over 20 kg with Human African Trypanosomiasis (HAT): a prospective, multicentre, open-label study, plug-in to the pivotal studyLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaAfrican trypanosomiasis Site CountriesDemocratic Republic of the Congo Source of Protocolhttps://dndi.org/wp-content/uploads/2020/06/DNDi-Clinical-Study-Protocol-FEX006-V5.pdf Approximate Page Count93 Date of Scientific Journal Publication9/27/2022 Scientific Journal Publicationhttps://www.thelancet.com/journals/langlo/article/PIIS2214-109X(22)00338-2/fulltext |
African trypanosomiasis | Africa |
Rivera, Luis |
A Phase III open-label randomized controlled study to evaluate the safety and immunogenicity of nOPV2 at different intervals of administration in infantsLink to ProtocolFirst Principal InvestigatorRivera, Luis Disease/Disease AreaPolio Site CountriesDominican Republic Source of Protocolclinicaltrials.gov Approximate Page Count64 Date of Scientific Journal Publication1/3/2024 Scientific Journal Publicationhttps://www.thelancet.com/journals/laninf/article/PIIS1473-3099(23)00519-4/fulltext |
Polio | South America |
Not listed |
Efficacy, Safety and Immunogenicity Study of GSK Biologicals’ Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or With-out Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of AgeLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaMalaria Sub AreaVAC Site CountriesGhana, Kenya Source of Protocolclinicaltrials.gov Approximate Page Count235 Date of Scientific Journal Publication9/9/2022 Scientific Journal Publicationhttps://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00273-0/fulltext |
Malaria | Africa |
Kayentao, Kassoum |
Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in a Dose-Escalation Trial in Adults and Children and a Randomized, Double-Blind Trial of Children in MaliLink to ProtocolFirst Principal InvestigatorKayentao, Kassoum Disease/Disease AreaMalaria Site CountriesMali Source of Protocolclinicaltrials.gov Approximate Page Count121 Date of Scientific Journal Publication5/2/2024 Scientific Journal Publicationhttps://www.nejm.org/doi/10.1056/NEJMoa2312775?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed |
Malaria | Africa |
Downloadable Clinical Trial Protocol Registry
Download the Clinical Trial Protocol Registry to access a detailed Excel spreadsheet of all the publicly available global health protocols included in the Protocol Library and the links to access them.
Protocol Library
The Protocol Library includes publicly available global health trial protocols (sorted into disease area folders).
Please note: Implementors of studies should also always refer to relevant regulatory standards and guidelines (e.g. FDA, EMA) to assist with study/protocol design.