Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202112683307570 Date of Approval: 14/12/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title CAPRISA 012C
Official scientific title A double-blinded, randomized, placebo-controlled phase II trial to assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV-negative women
Brief summary describing the background and objectives of the trial The CAPRISA 012C trial will evaluate the combination of CAP256V2LS and VRC07-523LS in young HIV-negative South African and Zambian women at 6-monthly dosing intervals. The overall goal of the CAPRISA 012 trials is to develop a new, safe and effective long-acting HIV prevention technology principally for women, to alter the course of the HIV epidemic in Africa
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CAPRISA 012C
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 15/11/2022
Actual trial start date 16/11/2022
Anticipated date of last follow up 14/12/2024
Actual Last follow-up date 21/07/2025
Anticipated target sample size (number of participants) 900
Actual target sample size (number of participants) 990
Recruitment status Recruiting
Publication URL not available yet
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1 A 20 mg/kg SC + 20 mg/kg SC at 16-week (4 monthly) dosing intervals Depending on the dosing interval and study product availability, participants will continue in follow up until approximately 16, 18 or 20 months CAP256V2LS + VRC07-523LS 328
Experimental Group Group 1B 20 mg/kg SC + 20 mg/kg SC at 24-week (6 monthly) dosing intervals Depending on the dosing interval and study product availability, participants will continue in follow up until approximately 16, 18 or 20 months CAP256V2LS + VRC07-523LS 328
Control Group Group 1C Normal saline SC at 16 or 24-week (4 or 6 monthly) dosing intervals Depending on the dosing interval and study product availability, participants will continue in follow up until approximately 16, 18 or 20 months Placebo 328 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
•18 to 30 years of age • Persons born Female (assigned female sex at birth) and identifying as female. • Able and willing to complete the informed consent process • Able to understand the information provided including the potential impact and/or risks linked to SC administration of the study product, willing to comply with protocol procedures, has access to the clinical research site and is available for follow-up for the study duration • Based on clinical assessment, participant must be in good general health as per opinion of the Principal Investigator (PI) or designee • Haemoglobin > 10g/dl • Creatinine ≤ 1.25 x ULN • ALT < 1.25 x ULN • HIV negative • Negative β-HCG (human chorionic gonadotropin) pregnancy test on day of enrolment • If of reproductive potential, has evidence of effective contraceptive use and is willing to adhere to effective contraceptive use during the study period • Sexually active in the last 3 months • Any significant acute or chronic medical condition, situation or circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study, or jeopardizes the safety or rights of the participant • If planning a pregnancy for the duration of the study, currently pregnant or breastfeeding • A history of alcohol or substance use judged by the PI to potentially interfere with participant study compliance • Prior participation in an investigational HIV vaccine trial, except if proof of allocation to the placebo arm is available. • Receipt of any vaccines within 28 days prior to enrolment • Administration of a monoclonal antibody or polyclonal immunoglobulin within 6 months prior to enrolment • Investigational HIV-related products received within 6 months prior to enrolment • Any history of anaphylaxis and related symptoms such as hives, respiratory difficulty, or angioedema • Evidence of autoimmune disease or currently receiving immunosuppressive therapy • Current participation in any other research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the PI/designee Adult: 19 Year-44 Year 18 Year(s) 30 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/11/2021 Biomedical Research Ethics Committee University of KwaZuluNatal
Ethics Committee Address
Street address City Postal code Country
238 Mazisi Kunene Rd, Glenwood Durban 4041 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary objectives • To evaluate the safety of subcutaneously administered CAP256V2LS and VRC07-523LS among young HIV-negative women Primary Endpoints • Proportion of participants with any grade 3 or higher solicited reactogenicity events within the first 3 days after administration of CAP256V2LS in combination with VRC07-523LS versus placebo • Proportion of participants with any grade 3 or higher unsolicited adverse events (AE) related to the administration of CAP256V2LS in combination with VRC07-523LS versus placebo Reactogenicity -Within the first 3 days after administration of CAP256V2LS in combination with VRC07-523LS and safety throughout study
Secondary Outcome Secondary objectives • To assess the plasma PK profile of study products administered at a fixed dose every 24 weeks • To compare HIV incidence rates in participants who receive antibodies against those receiving placebo • To assess CAP256V2LS and VRC07-523LS systemic and mucosal concentrations in relation to breakthrough HIV infections • To assess participant acceptability of the subcutaneous injections Secondary Endpoints • Differences in the PK profile of study products administered as weight-based dosing compared to fixed dosing • Documented HIV-1 infections after product administration during study follow-up • Differences in the systemic and mucosal concentrations of CAP256V2LS and VRC07-523LS titres among participants with breakthrough infection versus those without breakthrough infection • Proportion of participants reporting subcutaneous injections to be acceptable as per the study acceptability questionnaire Endpoints will be measure throughout the study at defined at 6, 12, 18 and 24 month timepoints
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CAPRISA eThekwini Clinical Research Site 3 University Ave, Greyville, Berea Durban 4000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
European and developing countries clinical trial partnership Anna van Saksenlaan 51 The Hague 2593 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CAPRISA 2nd floor Doris Duke Med Research Inst, 719 Umbilo Road, Congella Durban 4001 South Africa Research Sector
COLLABORATORS
Name Street address City Postal code Country
Centre for Infectious Disease Research in Zambia Plot 34620, Off Alick Nkhata Road Lusaka 34681 Zambia
University Jean Monnet 10 Rue Trefilerie, Cedex 2 Saint Etienne 42023 France
Amsterdam Institute for Global Health and Development AHTC, Tower C4, Paasheuvelweg Amsterdam 1105 Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Sharana Mahomed sharana.mahomed@caprisa.org +27813189848 2nd floor Doris Duke Med Research Inst, 719 Umbilo Road, Congella
City Postal code Country Position/Affiliation
Durban 4001 South Africa CAPRISA
Role Name Email Phone Street address
Principal Investigator Salim S Abdool Karim Salim.AbdoolKarim@caprisa.org +27312604550 Doris Duke Medical Research Institute,Nelson R Mandela School of Medicine,University of KwaZulu-Natal
City Postal code Country Position/Affiliation
Durban 4013 South Africa Director CAPRISA
Role Name Email Phone Street address
Public Enquiries Nqobile Myeni nqobile.myeni@caprisa.org 0027316550605 3 university Avenue, Greyville
City Postal code Country Position/Affiliation
Durban 4001 South Africa CAPRISA
Role Name Email Phone Street address
Public Enquiries Revina Munsamy revina.munsamy@caprisa.org 0714840572 3 University Avenue, Greyville
City Postal code Country Position/Affiliation
Durban 4001 South Africa CAPRISA
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results of the trial will be made publicly available in a timely manner by posting to the results section of the clinical trial registry. In addition, if not already available through a journal website, the datasets on which research papers have been published will be made available to any investigator Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of study completion To access data, investigators will need to lodge a request on the CAPRISA website (www.caprisa.org). The written request will be assessed by the CAPRISA Scientific Review Committee, and once approved, the dataset will be made available. In line with standard data access principles, CAPRISA will ensure that metadata on the datasets will be made available and anonymization and other measures will be taken to protect individual and personally identifiable information in the datasets.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information