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.: PACTR201705002290492 Date of Approval: 12/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title HVTN 705/VAC89220HPX2008
Official scientific title A multicenter, randomized, double-blind, placebo-controlled phase 2b efficacy study of a heterologous prime/boost vaccine regimen of Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 in preventing HIV-1 infection in adult women in sub-Saharan Africa
Brief summary describing the background and objectives of the trial The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminumphosphate adjuvanted Clade C gp140 for the prevention of Human Immuno Virus (HIV) infection in HIV seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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: Vaccines
Anticipated trial start date 01/09/2017
Actual trial start date 01/11/2017
Anticipated date of last follow up 31/01/2022
Actual Last follow-up date 02/02/2022
Anticipated target sample size (number of participants) 2600
Actual target sample size (number of participants) 2622
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
VAC89220HPX2008; HVTN 705; CR108263
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Treatment Ad26.Mos4.HIV 5 x 1010 vp: 0.5 mL Left deltoid - mnth 0, 3, 3,12; Co-formulated Clade C gp140 (250 mcg) with alumin phosphate adjuvant: 0.5mL RIGHT deltoid. (unless medical contraindicated: mnth 6,12 50 months intervention duration Vaccine 1300
Control Group Placebo 2 (P2) For: Ad26.Mos4.HIV - 0.5mL LEFT deltoid - mnth 0, 3, 6, 12; co-formulated Clade C gp 140 +alumin phospahte: 0.5mL RIGHT deltoid mnth 6,12 50 mnths intervention duration Placebo 1300 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sexually active, defined as having had sexual intercourse with a male partner at least twice in the past 30 days prior to screening, and is considered by the site staff to be at risk for Human Immunodeficiency Virus (HIV) infection; Access to a participating HIV Vaccine Trials Network (HVTN) Clinical Research Sites (CRS) and willingness to be followed for the planned duration of the study; Willingness to discuss HIV infection risks and willing to receive HIV risk reduction counseling and appropriate referrals to minimize HIV acquisition, as applicable; Negative beta human chorionic gonadotropin (betaHCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing; Participants must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until 3 months after the last vaccination Investigational research agents received within 30 days before first vaccination; HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 705/HPX2008 (Protocol Safety Review Team) PSRT will determine eligibility on a case by case basis; Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (example: measles, mumps, and rubella [MMR]¿ oral polio vaccine [OPV]¿ varicella¿ yellow fever); Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B); Immunosuppressive medications received within 6 months before first vaccination 18 Year(s) 35 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 07/04/2017 University of the Witwatersrand Human Research Ethics Committee (WHREC)
Ethics Committee Address
Street address City Postal code Country
8 Blackwood Avenue, Parktown Johannesburg 2193 South Africa
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 12/05/2017 University of Cape Town Human Research Ethics Committee (UCT HREC)
Ethics Committee Address
Street address City Postal code Country
Barnard Fuller Building, Anzio Road, Observatory Cape Town 7935 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 14/07/2017 Medical Research Council Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl Drive, Parowvallei Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 10/04/2017 University of KwaZulu-Natal Biomedical Research Ethics Committee (UKZN BREC)
Ethics Committee Address
Street address City Postal code Country
Research Office, Govan Mbeki Centre, Westville Campus Durban South Africa
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 12/05/2017 University of Pretoria Faculty of Health Sciences, Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Tswelopele Building, Level 4, Rooms 4-59 and 4-60 (opposite the BMS Building) Dr Savage Road, Gezina Pretoria 0007 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/12/2017 Sefako Makgatho Health Sciences University (SMU MeCRU)
Ethics Committee Address
Street address City Postal code Country
Molotlegi Street, Garankuwa Pretoria 0204 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 30/06/2017 Malawi National Health Sciences Research Committee
Ethics Committee Address
Street address City Postal code Country
College of Medicine, 3d Floor, John Chiphangwi Learning Resource Centre Chichiri, Blantyre 3 N/A Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No University of North Carolina Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
720 Martin Luther King Jr Blvd, Bldg 385, Second Floor, Chapel Hill North Carolina NC 27599-7097 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 28/07/2017 Mozambique INS Health Bioethics Institutional Committee
Ethics Committee Address
Street address City Postal code Country
N/A Mozambique
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 28/07/2017 US Military HIV Research Program (MHRP) Institutional Biosafety Committee
Ethics Committee Address
Street address City Postal code Country
6720A Rockledge Drive, Suite 400, Bethesda Maryland MD 20817 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 10/07/2017 Mozambique National Health Bioethics Committee
Ethics Committee Address
Street address City Postal code Country
N/A Mozambique
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/05/2017 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/05/2017 University of Alabama Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/05/2017 Emory University Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 12/06/2017 Zambia Ministry of Health, National Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 10/04/2017 University of Zimbabwe Joint Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Zimbabwe
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 17/03/2017 Chitungwiza City Health Department Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Vaccine Efficacy (VE) as Derived From Confirmed HIV1 Infections Diagnosed Between the Month 7 and Month 24 Visits From Month 7 to Month 24
Primary Outcome Local and systemic reactogenicity signs and symptoms for 3 days after each vaccination, adverse events for 30 days after each vaccination, and serious adverse events, AESIs, and adverse events leading to early participant withdrawal or early discontinuation of study product(s) administration for the entire duration of the study Reactogenicity for 3 days after each vaccination
Secondary Outcome Vaccine Efficacy as Derived From Confirmed HIV1 Infections Diagnosed Between Enrollment and the Month 24 Visit From Baseline to 24 Months
Secondary Outcome Vaccine efficacy as derived from confirmed HIV-1 infection diagnosed after enrollment through the end of the study if Stage 2 occurs Baseline up to end of study
Secondary Outcome Vaccine Efficacy as Derived From Confirmed HIV1 Infections Diagnosed Between the Month 12 and the Month 24 Visits From Month 12 to Month 24
Secondary Outcome Vaccine efficacy as derived from confirmed HIV-1 infection diagnosed from month 12 through the end of the study if Stage 2 occurs Month 12 up to end of study
Secondary Outcome Immunogenicity of the Vaccine Regimen Up to Month 24
Secondary Outcome Immunogenicity and Immune Response Biomarkers as Correlates of Risk of Subsequent HIV Acquisition Up to Month 24
Secondary Outcome Vaccine Efficacy Assessed by Various Baseline and Demographic Characteristics Up to Month 24
Secondary Outcome Genotypic Characteristics of Viral Sequences From HIV1 Infected Participants at HIV1 Diagnosis, Such as Signature Site Mutations Baseline up to 36 Months
Secondary Outcome Comparison of Genomic Sequences of Viral Isolates From HIV1 Infected Vaccine and Placebo Recipients and Assessment by Sieve Analysis Methods of Whether There is Evidence of VaccineInduced Immune Pressure on the Viral Sequences Baseline up to 36 Months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre for the AIDS Programme of Research in South Africa (CAPRISA), eThekwini Clinical Research Site 3 Richards Road Durban 4001 South Africa
South African Medical Research Council HIV Prevention Research Unit 12-14 Tesco Drive, Tongaat Durban 4400 South Africa
The Aurum Institute, Gavin J Churchyard Legacy Centre ¿ Klerksdorp Clinical Research Centre 201 Jade Square Centre, c/o OR Thambo and Margaretha Prinsloo Streets Klerksdorp 2571 South Africa
Qhakaza Mbokodo Research Clinic 15 Parklane Mkhamba Gardens, Ladysmith 3370 South Africa
Synexus SA, Stanza Clinical Research Centre 2 Shilovhane Street Mamelodi East 0122 South Africa
Desmond Tutu HIV Foundation, Masiphumelele Clinical Research Centre Guinea Fowl Road Sunnydale 7975 South Africa
The Aurum Institute, Rustenburg Clinical Research Centre First Floor, 50 Steen Street c/o Pretorius Street Rustenburg 0300 South Africa
Setshaba Research Centre 2088 Block H Soshanguve 0152 South Africa
Perinatal HIV Research Unit (PHRU) ¿ Baragwanath New Nurses Home, Chris Hani Baragwanath Hospital, Chris Hani Road Soweto 1862 South Africa
Perinatal HIV Research Unit (PHRU) ¿ Kliptown Office no. 7, Walter Sisulu Square, c/o Union and Klipspruit Valley Roads Kliptown, Soweto 1809 South Africa
The Aurum Institute, Tembisa Clinical Research Centre c/o Rev RTJ Namane and Flint Mazibuko Drive, Hospital View Tembisa 1632 South Africa
Nelson Mandela Clinical Research Unit, Albertina Sisulu Centre for Global Health, Walter Sisulu University Old Mthatha Hospital, 17 Hospital St Mthatha Central 5099 South Africa
Sefako Makgatho Health Sciences University (SMU MeCRU) Garankuwa Pretoria 0204 South Africa
Ndlovu Research Centre Stand 934 Elandsdoorn, Dennilton 0485 South Africa
Clinical Infectious Disease Research Initiative (CIDRI), University of Cape Town C/o Lwandile Road and Sulani Drive, Site B Clinic Health Care Facility, Research Clinic Khayelitsha 7784 South Africa
Centre for Family Health Research in Zambia 22A Lupili Road Ndola N/A Zambia
Polana Canico Health Research and Training Centre (CISPOC) 178 Avenida costa de Sol, Polana Canico B, Hospital Polan Canico, 3d Floor Maputo NA Mozambique
University of Zimbabwe - UCSF Seke South Clinic, Unit L, Seke South Chitungwiza, Mashonaland East N/A Zimbabwe
Centre for Infectious Disease Research in Zambia (CIDRZ) Matero 1st Level Hospital, Chitimukulu Road Matero, Lusaka N/A Zambia
UNC Lilongwe Project George Joaki Centre, Area 18, Health Centre, Road 18/12 (off M1 Road) Lilongwe N/A Malawi
JOSHA Research 28 East Burger Street Bloemfontein 9300 South Africa
Zambia Emory HIV Research Project (ZEHRP) - Lusaka B22/F737 Mwembelelo Road, Emmasdale Matero, Lusaka Zambia
Desmond Tutu HIV Foundation, Emavundleni Research Centre 14 Sonwabile Drive Old Crossroads, Klipfontein, Cape Town 7750 South Africa
South African Medical Research Council HIV Prevention Research Unit Chatsworth Clinical Research Site R.K. Khan Circle Chatsworth 4030 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Janssen Vaccines & Prevention B.V. Archimedesweg 4-6 Leiden 2333 CN Netherlands
The Division of AIDS (DAIDS), NIAID NIAID Office of Communications and Government Relations 5601 Fishers Lane Bethesda, MD MD 20892-9806 United States of America
Bill & Melinda Gates Foundation 500 Fifth Avenue North Seattle, Washington WA 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Janssen Vaccines & Prevention B.V. Archimedesweg 4-6 Leiden 2333 CN Netherlands Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
The HIV Vaccine Trials Network (HVTN) 1100 Eastlake Avenue East Seattle, Washington 98109 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Glenda Gray Glenda.Gray@mrc.ac.za +27219380905; +2783 4592680 South African Medical Research Council, Francie van Zijl Drive, Parow Valley
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa President & CEO, National PI, Protocol Chairs and a Member of the HVTN Executive Management Team
Role Name Email Phone Street address
Public Enquiries Lorenz Scheppler LScheppl@its.jnj.com +31 71-519-9181 JANSSEN VACCINES & PREVENTION B.V., Archimedesweg 4-6
City Postal code Country Position/Affiliation
Leiden 2333 CN Netherlands Global Regulatory Leader, HIV & HPV Vaccines
Role Name Email Phone Street address
Scientific Enquiries Glenda Gray Glenda.Gray@mrc.ac.za +27219380905; +27834592680 South African Medical Research Council Francie van Zijl Drive, Parow Valley
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa President & CEO, National PI, Protocol Chairs and a Member of the HVTN Executive Management Team
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu URL: https://www.janssen.com/clinical-trials/transparency Clinical Study Report 12 months after study completion Researchers
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.janssen.com/clinical-trials/transparency Yes 04/07/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 04/07/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information