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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR2008120000904116 Date of Registration: 11/12/2008
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety and immunogenicity of a candidate HIV-1 vaccine, MVA.HIVA, administered to healthy infants born to HIV-1/2-uninfected mothers.
Official scientific title Evaluation of safety and immunogenicity of a candidate HIV-1 vaccine, MVA.HIVA, in healthy infants born to HIV-1/2 uninfected mothers
Brief summary describing the background and objectives of the trial Aim: to develop vaccine for prevention of mother-to-child transmission of HIV-1 during breastfeeding. Objectives: To evaluate 1. Safety and immunogenicity of MVA.HIVA vaccine in 12-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers. 2. Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines when administered simultaneously to infants.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PV001
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 15/12/2009
Actual trial start date 15/12/2009
Anticipated date of last follow up 01/10/2010
Actual Last follow-up date 01/10/2010
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
Recruitment status Completed
Publication URL https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0078289
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 randomised to one of the two study groups of 24 by picking the next envelope (block randomised) assigning them to one of the two treatment groups Sealed envelopes Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised randomised to one of the two study groups of 24 by picking the next envelope (block randomised) assigning them to one of the two treatment groups Sealed envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control None None No vaccine or placebo given 24 Uncontrolled
Experimental Group MVA.HIVA 5x10^7 pfu 5x10^7 pfu of MVA.HIVA intramuscularly 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy infants, 12 weeks of age, with weight for age z-scores within 2 standard deviations of normal. Have received all standard EPI immunizations according to national immunization programme. Written informed consent by parent. Mother HIV-uninfected. Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory tract infection with or without low-grade febrile illness, i.e. axillary temperature of <37.5 °C ). Axillary temperature of ¿ 37.5 °C at the time of vaccination. Any clinically significant abnormal finding on screening from biochemistry or haematology at 8 weeks. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products. Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine. Invasive bacterial infections (pneumonia, meningitis). Any other on-going chronic illness requiring hospital specialist supervision. Administration of immunoglobulins and/or any blood products within one month preceding the planned administration of the vaccine candidate. Any history of anaphylaxis in reaction to vaccination. Research Physician's assessment of lack of willingness by parents to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the infant's risk of suffering an adverse outcome. Likelihood of travel away from the study area. Untreated malaria infection. 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 26/06/2008 Gambia Medical Research Council
Ethics Committee Address
Street address City Postal code Country
PO Box 273 Banjul PO Box 27 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Safety and immunogenicity of MVA.HIVA vaccine in 3-month-old healthy Gambian infants born to HIV-1/2-uninfected mothers 12 weeks old 13 weeks 20 weeks 36 weeks
Secondary Outcome Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, Hep B and OPV) when administered simultaneously to infants who received BCG vaccine within the first two weeks of life. The trial will not be powered to detect small interference effects. 12 weeks old 13 weeks 20 weeks 36 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sukuta Health Centre Sukuta Fajara Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP The Laan Van Nieuw Oost Indië 300 Den Haag 2593 CE Netherlands
EDCTP The Laan Van Nieuw Oost Indië 300 Den Haag 2593 CE Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Council UK 20 Park Crescent London W1B 1AL United Kingdom Charities/Societies/Foundation
Primary Sponsor Medical Research Council UK 20 Park Crescent London W1B 1AL United Kingdom Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Marie Reilly Nobels väg 12A Stockholm SE-17177 Sweden
Marie Reilly Nobels väg 12A Stockholm SE-17177 Sweden
Katie Flanagan MRC Laboratories, PO Box 273 Fajara Gambia
Katie Flanagan MRC Laboratories, PO Box 273 Fajara Gambia
Walter Jaoko Kenyatta National Hospital, Ngong Road Nairobi 00202 Kenya
Walter Jaoko Kenyatta National Hospital, Ngong Road Nairobi 00202 Kenya
Tomas Hanke John Radcliffe Hospital Oxford OX3 9DS United Kingdom
Tomas Hanke John Radcliffe Hospital Oxford OX3 9DS United Kingdom
Grace John-Stewart 325 Ninth Ave Seattle WA 98104 United States of America
Grace John-Stewart 325 Ninth Ave Seattle WA 98104 United States of America
Joan Joseph Hospital Clinic Barcelona, Infectious Diseases Department, AIDS Research Unit Barcelona 08036 Spain
Joan Joseph Hospital Clinic Barcelona, Infectious Diseases Department, AIDS Research Unit Barcelona 08036 Spain
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tomas Hanke tomas.hanke@ndm.ox.ac.uk +44 (0)1865 617630 ORCRB, Roosevelt Drive
City Postal code Country Position/Affiliation
Oxford OX3 7DQ United Kingdom Head of HIV-1 vaccine group, Oxford University Research Lecturer, Jenner Institute Investigator
Role Name Email Phone Street address
Public Enquiries Tomas Hanke tomas.hanke@ndm.ox.ac.uk +441865617630 ORCRB, Roosevelt Drive
City Postal code Country Position/Affiliation
Oxford OX3 7DQ United Kingdom Principal Investigator Jenner Institute
Role Name Email Phone Street address
Scientific Enquiries Tomas Hanke tomas.hanke@ndm.ox.ac.uk +44 (0)1865 617630 ORCRB, Roosevelt Drive
City Postal code Country Position/Affiliation
Oxford OX3 7DQ United Kingdom Head of HIV-1 vaccine group, Oxford University Research Lecturer, Jenner Institute Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Paper on safety and immunogenicity is available at https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0078289 Deidentified participant data will be made available upon requests directed to the chief investigator. Proposals will be reviewed and approved by the chief investigator and collaborators based on scientific merit. After approval of a proposal, data can be shared through a secure online platform after signing a data access agreement Study Protocol Upon request Scientific merit
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0078289 Yes 12/08/2024 24/10/2013
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 12/08/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information