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.: PACTR202003767867253 Date of Approval: 18/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title CAPRISA 012B
Official scientific title A Phase I Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of a Human Monoclonal Antibody, CAP256V2LS (VRC-HIVMAB0102-00-AB) administered intravenously to HIV-negative and HIV-positive women or subcutaneously alone and in combination with VRC07- 523LS and /or PGT121 to HIV-negative women in South Africa
Brief summary describing the background and objectives of the trial The research and development pathway of CAP256V2LS mAb has led to the CAPRISA 012 clinical trials programme. The CAPRISA 012A trial, which is currently underway, is a phase I study that assesses the safety and pharmacokinetics (PK) of VRC07-523LS and PGT121 mAbs individually and in combination. CAPRISA 012B, described here, is a phase I trial that evaluates the safety and PK of CAP256V2LS. Based on these phase I studies, a bnAb combination will be selected and evaluated in a larger CAPRISA 012C phase II trial. This trial will determine the extended safety and efficacy in preventing HIV infection in young women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CAPRISA 012B
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 01/04/2020
Actual trial start date 29/06/2020
Anticipated date of last follow up 31/12/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 76
Actual target sample size (number of participants) 76
Recruitment status Closed to recruitment,follow-up continuing
Publication URL https://www.sciencedirect.com/science/article/abs/pii/S2352301823000036
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 Dose escalation of IV administration of CAP256V2LS 5 mg/kg -20mg/kg IV one dose CAP256V2LS 22
Control Group Group 2 Dose escalation of SC administration of CAP256V2LS 5 -20mg/kg SC one dose one dose 16 weeks apart 24 weeks apart CAP256V2LS hyaluronidase 24 Uncontrolled
Experimental Group Group 3 Dose escalation of the two antibody combinations 10-20mg/kg SC one dose CAP256V2LS PGT121 VRC07-523.LS hyaluronidase placebo 15
Experimental Group Group 4 Three antibody combination 20mg/kg SC 5mg/kg SC 20mg/kg SC one dose CAP256V2LS PGT121 VRC07-523.LS hyaluronidase placebo 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
18 to 45 years of age • Born 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 IV and 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 • Neutrophil count within institutional normal range/accompanied by the PI/designee approval • Platelets within institutional normal range/ accompanied by the PI/designee approval • Creatinine < 1.1 x ULN • ALT < 1.25 x ULN • HIV negative as per FFDA-approved method of detection in last 30 days (for Groups with HIV negative participants only) • Negative β-HCG (human chorionic gonadotropin) pregnancy test • If of reproductive potential, has evidence of effective contraceptive use and is willing to adhere to effective contraceptive use during the study period • Willing to have blood samples collected, stored, and used for research purposes. • Willing to adhere to reduced risk sexual behaviour during study participation. Any clinically significant acute or chronic medical condition that in the opinion of the PI/designee makes the participant unsuitable for participation in the study, or jeopardises the safety or rights of the participant • If planning a pregnancy for the duration of the study, currently pregnant or breastfeeding • Exceeding the weight of 95 kilograms • 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 • Administration of a mAb or polyclonal immunoglobulin within 28 days 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 • Participants in the study may not take part in other concurrent 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) 45 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 11/03/2020 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 To evaluate the safety and tolerability of CAP256V2LS administered Throughout the study
Secondary Outcome Pharmacokinetics 4, 16, 24 weeks
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 flr Doris Duke Med Research Inst, 719 Umbilo Road, Congella Durban 4001 South Africa Research Centre
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 SaintEtienne 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 flr 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
Public Enquiries Kalendri Naidoo Kalendri.Naidoo@caprisa.org 0312604550 3 university Avenue, greyville
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
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