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.: PACTR201403000794397 Date of Approval: 17/03/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety & Immunogenicity of HIV Vaccines in Healthy Kenyan Adults (HIV-CORE 004)
Official scientific title A Phase I/IIa Clinical Trial of HIV-1 Vaccines pSG2.HIVconsv DNA, MVA.HIVconsv and Ad35-GRIN in Combined Regimens in Healthy HIV-1/2-negative Adults in Nairobi.
Brief summary describing the background and objectives of the trial The main objectives of this study are to determine the vaccines' safety and immunogenicity in an African population, and further strengthen the vaccine trial capacity in the South. HIV-CORE 004 is a double blind, placebo controlled randomized Phase I/IIa study designed to evaluate the safety and immunogenicity of different delivery regimens using three novel HIV-1 vaccines pSG2.HIVconsv DNA (D) with and without electroporation (e), adenovirus Ad35-GRIN (A) and poxvirus MVA.HIVconsv (M) administered by intramuscular needle injection in heterologous prime-boost regimens. 72 healthy, low-risk, HIV-1-uninfected adult volunteers in Nairobi will be randomly assigned to one of three groups, AM, DDDAM and DeDeDeAM each containing 20 vaccinees and 4 placebo recipients. Firstly, this study aims to evaluate the safety and tolerability of the vaccines pSG2.HIVconsv DNA (D) with and without electroporation (e), adenovirus Ad35-GRIN (A) and poxvirus MVA.HIVconsv (M). Secondly, we shall determine the effect of electroporation during DNA priming on the frequency, durability and/or quality of T cell responses (DDDAM vs DeDeDeAM). Thirdly, we shall determine whether priming with three DNA vaccinations with or without electroporation affects the frequency, durability and/or quality of T cell responses to the HIVconsv immunogen compared to that seen in the AM regimen (AM vs DDDAM/DeDeDeAM). As this is the first study of the combined HIVconsv vaccines in an African population, of the pSG2.HIVconsv DNA with electroporation, and the combination of the two HIVconsv vaccines with Ad35-GRIN, this trial has been designed as a pilot study to compare different vector combinations. The sample sizes will only allow detection of large response differences between volunteers in the three groups, thus, yielding data that are primarily descriptive.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HIV
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 24/03/2014
Actual trial start date 06/03/2014
Anticipated date of last follow up 30/11/2015
Actual Last follow-up date 03/08/2015
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
1006-13 Oxford Tropical Research Ethics Committee (OXTREC)
1006-13 Oxford Tropical Research Ethics Committee (OXTREC)
Kenyan Pharmacy & Poisons Board ECCT/13/07/01
HIV-CORE 004/ IAVI N004 Sponsor-issued trial number
Kenyatta National Hospital/University of Nairobi P11/01/2013
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 Permuted block randomisation Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ad35-GRIN or saline placebo; MVA.HIVconsv or saline placebo Ad35-GRIN 5 x 10^10 vp IM once at week 0, MVA.HIVconsv 2 x 10^8 pfu IM once at week 8 8 weeks 2 vaccinations 24
Experimental Group pSG2.HIVconsv, Ad35-GRIN, MVA.HIVconsv, pSG2.HIVconsv DNA 4 mg or saline placebo at weeks 0, 4 and 8. Ad35-GRIN 5 x 10^10 vp or saline placebo once at week 12. MVA.HIVconsv 2 x 10^8 pfu or saline placebo once at week 20. 20 weeks 5 vaccinations 24
Experimental Group Electroporated pSG2.HIVconsv DNA, Ad35-GRIN, MVA.HIVconsv Electroporated pSG2.HIVconsv DNA 4mg or electroporated saline placebo at weeks 0, 4 and 8. Ad35-GRIN 5 x 10^10 vp or saline placebo at week 12. MVA.HIVconsv 2 x 10^8 pfu or saline placebo at week 20. 20 weeks 5 vaccinations (3 with electroporation) 24
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy adults aged 18-50 Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study. Written informed consent. Willing to undergo HIV-1 testing, counselling and receive test results. All female volunteers must be willing to undergo urine pregnancy tests If sexually active using an effective method of contraception until at least 4 months after the last vaccination. Willing to forgo donating blood during the study Any relevant abnormality including history of immunodeficiency or autoimmune disease, or use of medication that is clinically significant, within the previous 6 months. (Use of inhaled steroids for asthma or topical steroids for localized skin conditions will not exclude a volunteer.) Any clinically significant medical condition that is considered progressive or would make the volunteer unsuitable for the study Any of the following: Haematology Haemoglobin < 9.0 g/dl for women and <11.0 g/dl for men Absolute Neutrophil Count (ANC) ¿ 1000 /mm3 Absolute Lymphocyte Count (ALC) ¿ 600 /mm3 Platelets ¿100,000 /mm3, ¿ 550,000 /mm3 Biochemistry Creatinine > 1.3 x upper limit of normal (ULN) Aspartate aminotransferase (AST) > 2.5 x ULN Alanine aminotransferase (ALT) > 2.5 x ULN Urinalysis Protein = 2+ or more Blood = 2+ or more (for women: before or after menses) Confirmed HIV-1 or HIV-2 infection, hepatitis B, hepatitis C or untreated syphilis If female, pregnant, planning a pregnancy up to 4 months after the last vaccination, or lactating Receipt of live attenuated vaccine within +/- 60 days of vaccination with Investigational Medicinal Product (IMP) Receipt of other vaccine within +/- 14 days of vaccination with the IMP Receipt of blood transfusion or blood products within the previous 6 months Participate in another IMP clinical trial within the previous 3 months or during this study Receipt of any investigational HIV-1 vaccine within the previous 6 years History of severe reactogenicity events after vaccination, or history of severe allergic reactions Smallpox vaccination < 3 years ago Major psychiatric illness < 3 years ago Allergy or hypersensitivity to latex, chronic skin problems, or skin and subcutaneous tissue thickness > 40 mm in either deltoid region Presence of an implantable device Current use of any electronic stimulation device Cardiac disease or a heart condition History of syncope or fainting episode within 1 year Seizure disorder or history of seizure 18 Year(s) 50 Year(s) Both
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 19/06/2013 Kenyatta National Hospital/University of Nairobi ERC
Ethics Committee Address
Street address City Postal code Country
PO Box 19676 Code 00202 Nairobi Kenya
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 23/09/2013 Oxford Tropical Medicine Research Ethics Committee, University of Oxford
Ethics Committee Address
Street address City Postal code Country
Joint Research Block 60, Churchill Hospital Oxford OX3 7LE United Kingdom
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 19/06/2013 Kenyatta National Hospital/University of Nairobi ERC
Ethics Committee Address
Street address City Postal code Country
PO Box 19676 Code 00202 Nairobi Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Vaccine Safety week 44: Proportion of volunteers who develop a grade 3 or 4 local reaction. Proportion of volunteers who develop a grade 3 or 4 systemic reaction
Secondary Outcome Vaccine immunogenicity Week 44: T cell responses will be determined initially by interferon-gamma enzyme-linked immunospot assay
Secondary Outcome Vaccine Safety Week 44: A descriptive summary of grade 3 of 4 local and systemic events including laboratory abnormalities. A descriptive summary of serious adverse events, including laboratory abnormalities
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KAVI- Kangemi Health Centre PO Box 19676-00202 Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
European & Developing Countries Clinical Trials Partnership PO Box 93015, 2509AA, The Hague 2593 CE Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Wellington square Oxford OX1 2JD United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
University of Nairobi PO Box 30197 Nairobi 00200 Kenya
Karolinska Institutet Nobels vag 5 Stockholm 171 77 Sweden
International AIDS Vaccine Initiative 125 Broad Street, 9th Floor New York New York 10004 United States of America
University of Oxford Wellington Square Oxford OX1 2JD United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Walter Jaoko wjaoko@kaviuon.org 254-2-2717694 Dept. of Medical Microbiology, University of Nairobi, 2nd Floor, PO Box 19676-00202, Off Ngong Road,
City Postal code Country Position/Affiliation
Nairobi Kenya Professor, University of Nairobi
Role Name Email Phone Street address
Public Enquiries Alison Crook alison.crook@ndm.ox.ac.uk 441865857450
City Postal code Country Position/Affiliation
Oxford United Kingdom Project Manager, University of Oxford
Role Name Email Phone Street address
Scientific Enquiries Tomas Hanke tomas.hanke@ndm.ox.ac.uk +44 1865 617630
City Postal code Country Position/Affiliation
Oxford United Kingdom Chief Investigator, University of Oxford
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information