Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern

NCT05168813 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CoVPN 3008UM1AI068614
• Study Type: interventional
• Target: 14,237
• Locations: 6 countries
• Sites: 43

Brief Summary

The study will evaluate the clinical efficacy of different dosing regimens of the Moderna COVID-19 mRNA vaccine (100 mcg) in preventing COVID-19 disease in people who are living with HIV or have comorbidities associated with elevated risk of severe COVID-19, with the different vaccine regimens assessed determined by whether the participant had evidence of prior SARS-CoV-2 infection at enrollment.

Conditions

SARS-CoV-2 Infection; HIV Infections; COVID-19

Keywords

SARS-CoV-2; HIV; COVID-19

Outcome Measures

Primary Outcomes (14)

• Part A: Number of Participants With a First Occurrence of CDC-defined COVID-19 Starting 1 Day After Month 0 Dose Until Month 6 Dose in FAS Cohort Between Analysis Group 1 (AG1) and Analysis Group 2-1 (AG2-1)

  The CDC-based COVID-19 endpoint is defined as the first occurrence of symptomatic NAAT-confirmed COVID-19 based on the following criteria: 1. At least ONE of the following systemic or respiratory symptoms: Fever (≥ 38C), chills, cough, shortness of breath and/or difficulty breathing, fatigue, muscle and/or body aches \[not related to exercise\], headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea, AND 2. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. Because additional NAAT testing was performed at Month 1 for AG1 but not AG2-1, NAAT results at Month 1 were not considered. 3. The symptom date and NAAT positive date must be within 14 days of each other. The date of a COVID-19 endpoint according to the CDC-based definition is the earlier date of a symptom and the date of positive NAAT that satisfy the criteria stated above. The CDC criteria do not require adjudication.

  1 day after Month 1 dose until Month 6 dose

• Part A: Number of Participants With a First Occurrence of COVE-defined COVID-19 Starting 1 Day After Month 0 Dose Until Month 6 Dose in FAS Cohort Between Analysis Group 1 (AG1) and Analysis Group 2-1 (AG2-1

  The COVE-based COVID-19 endpoint is defined as the first occurrence of adjudicated symptomatic NAAT-confirmed COVID-19 based on the following criteria (same as in the Moderna mRNA-1273 COVE trial): 1. At least TWO of the following systemic symptoms: Fever ≥ 38◦C), chills, myalgia, headache, sore throat, new loss of taste or smell, OR 2. At least ONE of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia, AND 3. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. The date of a COVID-19 endpoint is the later date of a symptom and the date of positive NAAT. The COVE criteria require adjudication.

  1 day after Month 0 dose until Month 6 dose

• Part A: Number of Participants With a First Occurrence of COVE-based Severe COVID-19 Starting 1 Day After Month 0 Dose Until Month 6 Dose in FAS Between Analysis Group 1 (AG1) and Analysis Group 2-1 (AG2-1)

  The COVE-based severe COVID-19 endpoint is defined as the first occurrence of a confirmed case of COVE-based COVID-19, plus any of the following: 1. Clinical signs indicative of severe systemic illness, Respiratory Rate ≥ 30 per minute, Heart Rate ≥ 125 beats per minute, SpO2 ≤ 93% on room air at sea level or PaO2/FIO2 less than 300 mm Hg, OR 2. Respiratory failure or Acute Respiratory Distress Syndrome (ARDS), (defined as needing high-flow oxygen, noninvasive or mechanical ventilation, or ECMO), evidence of shock (systolic blood pressure less than 90 mmHg, diastolic BP less than 60 mmHg or requiring vasopressors), OR 3. Significant acute renal, hepatic, or neurologic dysfunction, OR 4. Admission to an intensive care unit or death. The severe COVE criteria require adjudication.

  1 day after Month 0 dose until Month 6 dose

• Part B: Number of Participants With a First Occurrence of CDC-based COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Between Month 6 Monovalent and Bivalent Boost Groups

  The CDC-based COVID-19 endpoint is defined as the first occurrence of symptomatic NAAT-confirmed COVID-19 based on the following criteria: 1. At least ONE of the following systemic or respiratory symptoms: Fever (≥ 38C), chills, cough, shortness of breath and/or difficulty breathing, fatigue, muscle and/or body aches \[not related to exercise\], headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea, AND 2. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. 3. The symptom date and NAAT positive date must be within 14 days of each other. The date of a COVID-19 endpoint according to the CDC-based definition is the earlier date of a symptom and the date of positive NAAT that satisfy the criteria stated above. The CDC criteria do not require adjudication.

  14 days after Month 6 dose until end of follow up (up to 18 months)

• Part B: Number of Participants With a First Occurrence of COVE-based COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Between Month 6 Monovalent and Bivalent Boost Group

  The COVE-based COVID-19 endpoint is defined as the first occurrence of adjudicated symptomatic NAAT-confirmed COVID-19 based on the following criteria (same as in the Moderna mRNA-1273 COVE trial): 1. At least TWO of the following systemic symptoms: Fever ≥ 38◦C), chills, myalgia, headache, sore throat, new loss of taste or smell, OR 2. At least ONE of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia, AND 3. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. The date of a COVID-19 endpoint is the later date of a symptom and the date of positive NAAT. The COVE criteria require adjudication.

  14 days after Month 6 dose until end of follow up (up to 18 months)

• Part B: Number of Participants With a First Occurrence of COVE-based Severe COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Between Month 6 Monovalent and Bivalent Groups

  Statistical analyses were not performed because there are fewer than 7 severe COVE-based severe COVID-19 starting 14 days after Month 6 dose until end of follow up in RM6 cohort.

  14 days after Month 6 dose until end of follow up (up to 18 months)

• Part A: Number of Participants With Solicited Adverse Events in the Safety Subset

  All solicited adverse events/reactogenicity symptoms are followed until resolution and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, dated July 2017. Local reacto symptoms collected are: erythema/redness, induration/swelling, lymphadenopathy, and pain/tenderness. Systemic reacto symptoms collected are: arthralgia, chills, fever, headache, malaise/fatigue, myalgia, and nausea.

  Up to 7 days following Month 0 vaccination (all Study Groups) and up to 7 days following Month 1 vaccination (Study Groups 1 and 3)

• Part B: Number of Participants With Solicited Adverse Events in the Safety Subset

  All solicited adverse events/reactogenicity symptoms are followed until resolution and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, dated July 2017. Local reacto symptoms collected are: erythema/redness, induration/swelling, lymphadenopathy, and pain/tenderness. Systemic reacto symptoms collected are: arthralgia, chills, fever, headache, malaise/fatigue, myalgia, and nausea.

  Up to 7 days following Month 6 vaccination

• Part A: Number of Participants With Unsolicited Adverse Events in the Safety Subset

  All unsolicited AEs are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017.

  Up to 28 days following Month 0 vaccination (all Study Groups) and up to 28 days following Month 1 vaccination (Study Groups 1 and 3)

• Part B: Number of Participants With Unsolicited Adverse Events in the Safety Subset

  All unsolicited AEs are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017.

  Up to 28 days following Month 6 vaccination

• Part A: Number of Participants With Serious Adverse Events (SAEs)

  An SAE is any AE that results in any of the following outcomes: death, a life-threatening adverse event, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, or is medically important.

  Up to Month 6

• Part B: Number of Participants With Serious Adverse Events (SAEs)

  An SAE is any AE that results in any of the following outcomes: death, a life-threatening adverse event, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, or is medically important.

  Day of Month 6 vaccination up to Month 18

• Part A: Number of Participants With Adverse Events of Special Interest (AESIs)

  Adverse events of special interest (AESI) were described in Appendix L of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.

  Up to Month 6

• Part B: Number of Participants With Adverse Events of Special Interest (AESIs)

  Adverse events of special interest (AESI) were described in Appendix L of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.

  Day of Month 6 vaccination up to Month 18

Secondary Outcomes (11)

• Part A: Number of Participants With First CDC-based COVID-19 Occurrence From 1 Day After Month 0 Dose to Month 6 Dose in FAS Cohort, Comparing Baseline SARS-CoV-2 Negative vs Positive, Regardless of HIV Status

  1 day after Month 0 dose until Month 6 dose

• Part A: Number of Participants With First COVE-based COVID-19 Occurrence From 1 Day After Month 0 Dose to Month 6 Dose in FAS Cohort, Comparing Baseline SARS-CoV-2 Negative vs Positive, Regardless of HIV Statu

  1 day after Month 0 dose until Month 6 dose

• Part A: Number of Participants With First COVE-based Severe COVID-19 Occurrence From 1 Day After Month 0 Dose to Month 6 Dose in FAS Cohort, Comparing Baseline SARS-CoV-2 Negative vs Positive, Regardless of HI

  1 day after Month 0 dose until Month 6 dose

• Part B: Number of Participants With a First Occurrence of CDC-based COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Who Have Month 6 Hybrid Immunity Between Month 6 Monovalent and Bivalent Boost Groups

  14 days after Month 6 dose until end of follow up (up to 18 months)

• Part B: Number of Participants With a First Occurrence of CDC-based COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Who Have Month 6 Vaccine Immunity Between Month 6 Monovalent and Bivalent Boost Group

  14 days after Month 6 dose until end of follow up (up to 18 months)

Study Arms (6)

Study Group 1

EXPERIMENTAL

COVID-19 mRNA vaccine in 100 mcg dose to be administered as an IM injection into the deltoid muscle on Months 0, 1, and 6 among adults living with HIV who are SARS-CoV-2 negative at baseline.

Biological: Moderna mRNA-1273; Biological: Moderna mRNA-1273.222; Biological: Vaccine 3 Dose

Study Group 2

EXPERIMENTAL

COVID-19 mRNA vaccine in 100 mcg dose to be administered as an IM injection into the deltoid muscle on Months 0 and 6 among adults living with HIV who are SARS-CoV-2 positive at baseline.

Biological: Moderna mRNA-1273; Biological: Moderna mRNA-1273.222; Biological: Vaccine 2 Dose

Study Group 3

EXPERIMENTAL

COVID-19 mRNA vaccine in 100 mcg dose to be administered as an IM injection into the deltoid muscle on Months 0, 1, and 6 among HIV negative adults who are SARS-CoV-2 negative at baseline.

Biological: Moderna mRNA-1273; Biological: Moderna mRNA-1273.222; Biological: Vaccine 3 Dose

Study Group 4

EXPERIMENTAL

COVID-19 mRNA vaccine in 100 mcg dose to be administered as an IM injection into the deltoid muscle on Months 0 and 6 among HIV negative adults who are SARS-CoV-2 positive at baseline.

Biological: Moderna mRNA-1273; Biological: Moderna mRNA-1273.222; Biological: Vaccine 2 Dose

Monovalent

EXPERIMENTAL

mRNA-1273 vaccine in 100 mcg dose to be administered as an IM injection into the deltoid muscle on Month 6.

Biological: Moderna mRNA-1273

Bivalent

EXPERIMENTAL

mRNA-1273.222 vaccine in 100 mcg dose to be administered as an IM injection into the deltoid muscle on Month 6.

Biological: Moderna mRNA-1273.222

Interventions

Moderna mRNA-1273 BIOLOGICAL

COVID-19 vaccine (mRNA-1273) developed by Moderna, Inc. is a lipid nanoparticle (LNP) dispersion of a messenger ribonucleic acid (mRNA) encoding the prefusion stabilized S protein of SARS-CoV-2 formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially available).

Monovalent; Study Group 1; Study Group 2; Study Group 3; Study Group 4

Moderna mRNA-1273.222 BIOLOGICAL

COVID-19 vaccine (mRNA-1273.222) developed by Moderna, Inc. is an updated bivalent version of Moderna's mRNA-1273 vaccine, composed of equal parts of mRNA-1273 and mRNA that encodes the S protein of the Omicron subvariants BA.4/.5 (which have the same S protein).

Bivalent; Study Group 1; Study Group 2; Study Group 3; Study Group 4

Vaccine 3 Dose BIOLOGICAL

COVID-19 mRNA vaccine in 100 mcg dose given as IM injection into the deltoid muscle on Months 0, 1, and 6.

Study Group 1; Study Group 3

Vaccine 2 Dose BIOLOGICAL

COVID-19 mRNA vaccine is to be administered as IM injection into the deltoid muscle on Months 0 and 6.

Study Group 2; Study Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General and Demographic Criteria
• Age ≥ 18 years if participant self-reports living with HIV or another comorbidity known to be associated with severe COVID-19, for example (CDC.gov for exhaustive list):
• Hypertension
• Type 2 diabetes mellitus
• Overweight, obese, or severely obese (ie, body mass index \[BMI\] ≥ 25 kg/m2)
• Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
• Chronic kidney disease
• COPD (chronic obstructive pulmonary disease)
• Cancer
• Non-HIV immunocompromised state (weakened immune system) or solid organ transplant
• Pregnancy
• Sickle cell disease
• Smoking
• Willingness to be followed and remain in the catchment area for the planned duration of the study.
• Ability and willingness to provide informed consent.

You may not qualify if:

• General
• Acutely ill 72 hours prior to or at screening. Participants meeting this criterion may be rescheduled within the relevant window periods. Participants with minor illnesses can be enrolled at the discretion of the investigator.
• History of angioedema or anaphylaxis.
• Vaccines and other injections
• Prior receipt of a SARS-CoV-2 vaccine.
• History of severe allergic reaction to any ingredient of this vaccine (lipids (SM-102, polyethylene glycol \[PEG\] 2000 dimyristoyl glycerol \[DMG\], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine \[DSPC\]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose).
• Live attenuated vaccines received within 30 days before first vaccination (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; live attenuated influenza vaccine, live attenuated zoster vaccine).
• Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, human papilloma virus (HPV), pneumococcal, Hepatitis A or B).
• Blood products, systemic immunoglobulins, or monoclonal antibodies (including against SARS-CoV-2) received within 90 days before first vaccination.

Sponsors & Collaborators

• COVID-19 Prevention Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Medical Research Council, South Africa: collaborator

Study Sites (47)

Gaborone CRS

Gaborone, Botswana

Location

Eswatini Prevention Center CRS

Mbabane, Hhohho Region, Eswatini

Location

Moi University Clinical Research Centre

Eldoret, Kenya

Location

Kisumu - Kombewa CRS

Kisumu, 40100, Kenya

Location

Kisumu Crs

Kisumu, Kenya

Location

Blantyre CRS

Blantyre, Malawi

Location

Malawi CRS

Lilongwe, Malawi

Location

Synergy Biomed Research Institute

East London, Eastern Cape, South Africa

Location

Nelson Mandela Academic Research Unit CRS

Mthatha, Eastern Cape, South Africa

Location

PHOENIX Pharma (Pty) Ltd

Port Elizabeth, Eastern Cape, South Africa

Location

Josha Resarch CRS

Bloemfontein, Free State, South Africa

Location

MeCRU CRS

Ga-Rankuwa, Gauteng, South Africa

Location

Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS

Johannesburg, Gauteng, South Africa

Location

Newtown Clinical Research

Johannesburg, Gauteng, South Africa

Location

Soweto - Bara CRS

Johannesburg, Gauteng, South Africa

Location

Wits RHI Ward 21 CRS

Johannesburg, Gauteng, South Africa

Location

MERC Kempton Park

Pretoria, Gauteng, South Africa

Location

Synexus Stanza Clinical Research Centre (CRS)

Pretoria, Gauteng, South Africa

Location

Tembisa Clinic 4 CoVPN CRS

Tembisa, Gauteng, South Africa

Location

CAPRISA eThekwini CRS

Durban, KwaZulu-Natal, South Africa

Location

Tongaat CRS

Durban, KwaZulu-Natal, South Africa

Location

Vulindlela CRS

Durban, KwaZulu-Natal, South Africa

Location

Isipingo CRS

Isipingo, KwaZulu-Natal, South Africa

Location

Qhakaza Mbokodo Research Clinic CRS

Ladysmith, KwaZulu-Natal, South Africa

Location

MERC Middelburg

Middelburg, Mpumalanga, South Africa

Location

Aurum Institute Klerksdorp CRS

Klerksdorp, North West, South Africa

Location

Rustenburg CRS

Rustenburg, North West, South Africa

Location

Emavundleni CRS

Cape Town, Western Cape, South Africa

Location

FAM-CRU (Family Clinical Research Unit)

Cape Town, Western Cape, South Africa

Location

Groote Schuur HIV CRS

Cape Town, Western Cape, South Africa

Location

Masiphumelele Clinical Research Site (MASI) CRS

Cape Town, Western Cape, South Africa

Location

TASK Central

Cape Town, Western Cape, South Africa

Location

Univeristy of Cape Town Lung CRS Institute

Cape Town, Western Cape, South Africa

Location

TASK Eden

George, Western Cape, South Africa

Location

Synexus Helderberg

Stellenbosch, Western Cape, South Africa

Location

Ndlovu Research Centre CoVPN CRS

Elandsdoorn, South Africa

Location

Kliptown Soweto CRS

Johannesburg, South Africa

Location

PHRU Matlosana CRS

Klerksdorp, South Africa

Location

MERC Welkom

Welkom, South Africa

Location

UVRI-IAVI HIV Vaccine Program LTD. CRS

Entebbe, Uganda

Location

Baylor-Uganda CRS

Kampala, Uganda

Location

Joint Clinical Research Centre

Kampala, Uganda

Location

MU-JHU Research Collaboration CRS

Kampala, Uganda

Location

Cfhrz Crs

Lusaka, Zambia

Location

Matero Reference Clinic CRS

Lusaka, Zambia

Location

UNC Global Projects / Kamwala District Health Centre

Lusaka, Zambia

Location

Zambia Emory HIV Research Project - Ndola CoVPN CRS

Ndola, Zambia

Location

Related Publications (1)

• Garrett N, Tapley A, Hudson A, Dadabhai S, Zhang B, Mgodi NM, Andriesen J, Takalani A, Fisher LH, Kee JJ, Magaret CA, Villaran M, Hural J, Andersen-Nissen E, Ferarri G, Miner MD, Le Roux B, Wilkinson E, Lessells R, de Oliveira T, Odhiambo J, Shah P, Polakowski L, Yacovone M, Samandari T, Chirenje Z, Elyanu PJ, Makhema J, Kamuti E, Nuwagaba-Biribonwoha H, Badal-Faesen S, Brumskine W, Coetzer S, Dawson R, Delany-Moretlwe S, Diacon AH, Fry S, Gill KM, Ebrahim Hoosain ZA, Hosseinipour MC, Inambao M, Innes C, Innes S, Kalonji D, Kasaro M, Kassim P, Kayange N, Kilembe W, Laher F, Malahleha M, Maluleke VL, Mboya G, McHarry K, Mitha E, Mngadi K, Mda P, Moloantoa T, Mutuluuza CK, Naicker N, Naicker V, Nana A, Nanvubya A, Nchabeleng M, Otieno W, Potgieter EL, Potloane D, Punt Z, Said J, Singh Y, Tayob MS, Vahed Y, Wabwire DO, McElrath MJ, Kublin JG, Bekker LG, Gilbert PB, Corey L, Gray GE, Huang Y, Kotze P; CoVPN 3008 Ubuntu Study Team. Hybrid versus vaccine immunity of mRNA-1273 among people living with HIV in East and Southern Africa: a prospective cohort analysis from the multicentre CoVPN 3008 (Ubuntu) study. EClinicalMedicine. 2025 Jan 20;80:103054. doi: 10.1016/j.eclinm.2024.103054. eCollection 2025 Feb.

  PMID: 39902315 RESULT

MeSH Terms

Conditions

COVID-19; HIV Infections

Interventions

2019-nCoV Vaccine mRNA-1273; Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: Yunda Huang, PhD, Multiple Principal Investigator, HVTN Statistical and Data Management Center
• Organization: Fred Hutchinson Cancer Center

hvtn.covpn.sdmc@hvtn.org

206-667-5780

Study Officials

• Nigel Garrett

  Centre for the AIDS Programme of Research in South Africa (CAPRISA)

  STUDY CHAIR

• Philip Kotze

  Qhakaza Mbokodo Research Clinic

  STUDY CHAIR

• Sufia Dadabhai

  Blantyre CRS / Johns Hopkins Research Project

  STUDY CHAIR

• Nyaradzo Mgodi

  University of Zimbabwe Clinical Trials Research Centre

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: December 23, 2021
• Study Start: December 1, 2021
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: April 21, 2026
• Results First Posted: November 26, 2025

Record last verified: 2026-04

Locations

UG (4); ZA (32); MA (2); BO (1); ES (1); KE (3)