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:

  1. A table of all of the clinical trial protocols included in the Protocol Library
  2. A downloadable Excel registry list of all the clinical trial protocols included in the Protocol Library
  3. 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 Philippines

Link to Protocol

First 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 trial

Link to Protocol

First 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 Infants

Link to Protocol

First 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 OPV

Link to Protocol

First 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 Women

Link to Protocol

First 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 Africa

Link to Protocol

First 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 Mexico

Link to Protocol

First 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 Infants

Link to Protocol

First 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 regimen

Link to Protocol

First 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 Infants

Link to Protocol

First 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 volvulus

Link to Protocol

First 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 Infants

Link to Protocol

First 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 Africa

Link to Protocol

First 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 Malaysia

Link to Protocol

First 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 Faso

Link to Protocol

First 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 years

Link to Protocol

First 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 study

Link to Protocol

First 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 infants

Link to Protocol

First 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 Age

Link to Protocol

First 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 Mali

Link to Protocol

First 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).

Human Immunodeficiency Virus

Neglected Tropical Diseases

Tuberculosis

Malaria

Maternal, Newborn, & Child Health

Nutrition

Vaccines

Enteric & Diarrheal Diseases

Pneumonia

Polio

Women's Health Innovations

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.