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 |
| Thirm, V D |
A PHASE III, RANDOMIZED, PARTIALLY DOUBLE-BLIND, ACTIVE CONTROL STUDY TO COMPARE THEIMMUNOGENICITY AND SAFETY OF A LIQUID FORMULATION OF ROTAVIN WITH THE CURRENTLY LICENSED FROZEN FORMULATION OF THE VACCINE (ROTAVIN-M1),IN HEALTHY VIETNAMESE INFANTS.Link to ProtocolFirst Principal InvestigatorThirm, V D Disease/Disease AreaRotavirus Sub AreaVAC Site CountriesVietnam Source of ProtocolVaccine Approximate Page Count98 Date of Scientific Journal Publication7/22/2021 Scientific Journal Publicationhttps://www.sciencedirect.com/science/article/pii/S0264410X21008069?via%3Dihub |
Rotavirus | Asia |
| Ruttmann, Ricardo |
A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine First Principal InvestigatorRuttmann, Ricardo Disease/Disease AreaPolio Sub AreaVAC Site CountriesPanama Source of ProtocolLancet Approximate Page Count82 Date of Scientific Journal Publication1/2/2021 Scientific Journal Publicationhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7811205/ |
Polio | Central America |
| Rivera, Luis |
A Phase 3, Open-label, Multicenter Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Latin American Infants First Principal InvestigatorRivera, Luis Disease/Disease AreaPolio Sub AreaVAC Site CountriesPanama, Dominican Republic Source of ProtocolLancet Infectious Dis Approximate Page Count62 Date of Scientific Journal Publication4/21/2021 Scientific Journal Publicationhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7992032/ |
Polio | Central America, Caribbean |
| Not listed |
A Phase 2, multi-center, randomized, open-label, dose escalation study to determine safety of single (QD) and multiple (3 QD) doses of KAE609, given to adults with uncomplicated Plasmodium falciparum malaria First Principal InvestigatorNot listed Disease/Disease AreaMalaria Sub AreaVAC Site CountriesMali, Gabon, Ghana, Uganda, Rwanda Source of Protocolclinicaltrials.gov Approximate Page Count76 Date of Scientific Journal Publication5/15/2022 Scientific Journal Publicationhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9155642/ |
Malaria | Africa |
| Mathad, Jyoti |
A Phase I/II Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-1-infected and HIV-1-uninfected Pregnant and Postpartum Women with Latent Tuberculosis InfectionLink to ProtocolFirst Principal InvestigatorMathad, Jyoti Disease/Disease AreaTB Sub AreaHIV Site CountriesHaiti, Kenya, Malawi, Thailand, Zimbabwe Source of Protocolclinicaltrials.gov Approximate Page Count80 Date of Scientific Journal Publication5/1/2022 Scientific Journal Publicationhttps://academic.oup.com/cid/article/74/9/1604/6330598?login=false |
TB | Africa |
| Not listed |
An Open Label, Non-comparative, Multicenter Study to Assess the Pharmacokinetics, Safety and Efficacy of Tafenoquine (SB252263, WR238605) in the Treatment of Pediatric Subjects with Plasmodium vivax Malaria First Principal InvestigatorNot listed Disease/Disease AreaMalaria Site CountriesVietnam, Colombia Source of Protocolclinicaltrials.gov Approximate Page Count123 Date of Scientific Journal Publication12/3/2021 Scientific Journal Publicationhttps://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(21)00328-X/fulltext |
Malaria | Asia, South America |
| Mhamilawa, Lwidiko Edward |
Aiming at prolonging the therapeutic life span of artemisinin-based combination therapies in an era of imminent Plasmodium falciparum resistance in Bagamoyo District, Tanzania – new strategies with old tools.Link to ProtocolFirst Principal InvestigatorMhamilawa, Lwidiko Edward Disease/Disease AreaMalaria Site CountriesTanzania Source of Protocolclinicaltrials.gov Approximate Page Count92 Date of Scientific Journal Publication6/23/2020 Scientific Journal Publicationhttps://malariajournal.biomedcentral.com/articles/10.1186/s12936-020-03287-5 |
Malaria | Africa |
| Dondorp, A.M. |
A multi-centre, open-label randomised trial to assess the efficacy, safety and tolerability of the Triple ACT artemether-lumefantrine+amodiaquine (AL+AQ) compared to the ACT artemether-lumefantrine (AL) in uncomplicated falciparum malaria in Cambodia and VietnamLink to ProtocolFirst Principal InvestigatorDondorp, A.M. Disease/Disease AreaMalaria Site CountriesCambodia, Vietnam Source of Protocolclinicaltrials.gov Approximate Page Count48 Date of Scientific Journal Publication3/8/2022 Scientific Journal Publicationhttps://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00692-7/fulltext |
Malaria | Asia |
| Not listed |
A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected WomenLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaHIV Site CountriesMulti Source of Protocolclinicaltrials.gov Approximate Page Count230 Date of Scientific Journal Publication4/1/2022 Scientific Journal Publicationhttps://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00538-4/fulltext |
HIV | Africa |
| Not listed |
A Phase II randomised, double blind, parallel group dose-ranging study of oral RV3-BB Rotavirus Vaccine administered at a titre of 1×107, 3 x 106 or 1 x 106 as a 3 dose neonate schedule or administered at a titre of 1x107as a 3 dose infant scheduleLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaRotavirus Sub AreaVAC Site CountriesMalawi Source of Protocolclinicaltrials.gov Approximate Page Count66 Date of Scientific Journal Publication1/20/2022 Scientific Journal Publicationhttps://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00473-4/fulltext |
Rotavirus | Africa |
| Ella, Raches |
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 Infants.Link to ProtocolFirst Principal InvestigatorElla, Raches Disease/Disease AreaRotavirus Sub AreaVAC Site CountriesZambia Source of ProtocolVaccine Approximate Page Count100 Date of Scientific Journal Publication6/16/2021 Scientific Journal Publicationhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8204902/ |
Rotavirus | Africa |
| Conradie, F. |
A Phase 3 partially-blinded, randomized trial assessing the safety and efficacy of various doses and treatment durations of linezolid plus bedaquiline and pretomanid in participants with pulmonary infection of either extensively drug-resistant tuberculosis (XDRTB), pre-XDR-TB or treatment intolerant or non-responsive multidrug resistant tuberculosis (MDR-TB).Link to ProtocolFirst Principal InvestigatorConradie, F. Disease/Disease AreaTB Sub AreaHIV Site CountriesMulti Source of ProtocolNEJM Approximate Page Count297 Date of Scientific Journal Publication9/1/2022 Scientific Journal Publicationhttps://www.nejm.org/doi/10.1056/NEJMoa2119430?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed |
TB | Multi |
| Clarke, Ed |
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, Lot-to-Lot Consistency, Immunogenicity, and NonInterference with Concomitant Vaccinations of Serum Institute of India’s 10-Valent Pneumococcal Conjugate Vaccine (PNEUMOSIL®) in Healthy Infants in The GambiaLink to ProtocolFirst Principal InvestigatorClarke, Ed Disease/Disease AreaPneumonia Sub AreaVAC Site CountriesThe Gambia Source of Protocolclinicaltrials.gov Approximate Page Count90 Date of Scientific Journal Publication1/28/2021 Scientific Journal Publicationhttps://pubmed.ncbi.nlm.nih.gov/33516293/ |
Pneumonia | Africa |
| Not listed |
A Randomized, Double-Blind (Sponsor-unblinded), Placebo-Controlled, Adaptive Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokineticsof GSK3640254 in HIV-1 Infected Treatment-Naïve AdultsLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaHIV Site CountriesMulti Source of Protocolclinicaltrials.gov Approximate Page Count153 Date of Scientific Journal Publication9/14/2022 Scientific Journal Publicationhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9536290/ |
HIV | Multi |
| Not listed |
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Eight Weeks Later in Children Infected with Human Immunodeficiency Virus (HIV) (PNEUWAY PED)Link to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaHIV Sub AreaVAC Site CountriesSouth Africa, Thailand, Ukraine Source of Protocolclinicaltrials.gov Approximate Page Count121 Date of Scientific Journal Publication7/1/2023 Scientific Journal Publicationhttps://journals.lww.com/aidsonline/Fulltext/2023/07010/A_phase_3_study_of_safety_and_immunogenicity_of.7.aspx |
HIV | Multi |
| Not listed |
A Phase III, randomized, multicenter, open-label, non-inferiority study evaluating the efficacy, safety and tolerability of switching to dolutegravir/lamivudine fixed dose combination in HIV-1 infected adults who are virologically suppressedLink to ProtocolFirst Principal InvestigatorNot listed Disease/Disease AreaHIV Site CountriesMulti Source of Protocolclinicaltrials.gov Approximate Page Count171 Date of Scientific Journal Publication2/18/2023 Scientific Journal Publicationhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10021070/ |
HIV | Multi |
| 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 |
| Musoke, Philippa |
Phase IV Evaluation of the Steady State Pharmacokinetics of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in Severely Malnourished HIV-1-Infected ChildrenLink to ProtocolFirst Principal InvestigatorMusoke, Philippa Disease/Disease AreaHIV Site CountriesMulti Source of Protocolclinicaltrials.gov Approximate Page Count99 Date of Scientific Journal Publication5/1/2021 Scientific Journal Publicationhttps://journals.lww.com/pidj/fulltext/2021/05000/pharmacokinetics_and_safety_of_zidovudine,.13.aspx |
HIV | Africa |
| Diawara, Halimatou and Duffy, Patrick |
Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali First Principal InvestigatorDiawara, Halimatou and Duffy, Patrick Disease/Disease AreaMalaria Sub AreaVAC Site CountriesMali Source of Protocolclinicaltrials.gov Approximate Page Count87 Date of Scientific Journal Publication11/29/2019 Scientific Journal Publicationhttps://academic.oup.com/cid/article/71/11/2849/5647428?login=false |
Malaria | Africa |
| Weil, Gary |
Community Based Safety and Efficacy Study of 2-drug (Diethylcarbamazine and Albendazole) versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis in IndonesiaLink to ProtocolFirst Principal InvestigatorWeil, Gary Disease/Disease AreaFilariasis Site CountriesIndonesia Source of Protocolclinicaltrials.gov Approximate Page Count108 Date of Scientific Journal Publication6/25/2019 Scientific Journal Publicationhttps://pubmed.ncbi.nlm.nih.gov/31233507/ |
Filariasis | Asia |
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.
