Home
 


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: www.pactr.org

Trial no.: PACTR2008120000904116 Date registered: 2008/11/10
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 HIV/AIDS ,
Purpose of the trial Prevention
Anticipated trial start date 2009-12-15
Actual trial start date 2009-12-15
Anticipated date of last follow up 2010-10-01
Actual date of last follow up 2010-10-01
Anticipated target sample size (number of participants) 48   
Actual target sample size (number of participants) 48   
Recruitment status Closed to recruitment: follow up complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
SCC1106 MRC Gambia Scientific Coordinating Committee Study

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

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

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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. 20 nulls 20 nulls 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 Oxford Tropical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Block 60, Old Road, Churchill Hospital Oxford OX3 7LJ United Kingdom

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 Foundation
Primary Sponsor Medical Research Council UK 20 Park Crescent London W1B 1AL United Kingdom Foundation

COLLABORATORS
Name Street address City Postal code Country
Walter Jaoko Kenyatta National Hospital, Ngong Road Nairobi 00202 Kenya
Tomas Hanke John Radcliffe Hospital Oxford OX3 9DS United Kingdom
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
Marie Reilly Nobels väg 12A Stockholm SE-17177 Sweden
Katie Flanagan MRC Laboratories, PO Box 273 Fajara Gambia
Walter Jaoko Kenyatta National Hospital, Ngong Road Nairobi 00202 Kenya
Tomas Hanke John Radcliffe Hospital Oxford OX3 9DS United Kingdom
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
Marie Reilly Nobels väg 12A Stockholm SE-17177 Sweden
Katie Flanagan MRC Laboratories, PO Box 273 Fajara Gambia

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Tomas Hanke tomas.hanke@imm.ox.ac.uk +44 (0)1865 222355 +44 (0)1865 222502
Street address City Postal code Country Position / Affiliation
Weatherall Institute of Molecular Medicine, JR Hospital Oxford OX3 9DS United Kingdom MRC Tenure Scientist, Oxford University Research Lecturer, Jenner Institute Investigator
Role Name Email Phone Fax
Public Enquiries Dr Tomas Hanke tomas.hanke@imm.ox.ac.uk +44 1865 222355 +44 1865 222502
Street address City Postal code Country Position / Affiliation
John Radcliffe Hospital Oxford OX3 9DS United Kingdom MRC Tenure Scientist, Oxford University Research Lecturer, Jenner Institute Investigator
Role Name Email Phone Fax
Scientific Enquiries Prof Tomas Hanke tomas.hanke@ndm.ox.ac.uk +44 (0)1865 617630 +44 (0)1865 617608
Street address City Postal code Country Position / Affiliation
ORCRB, Roosevelt Drive Oxford OX3 7DQ United Kingdom Head of HIV-1 vaccine group, Oxford University Research Lecturer, Jenner Institute Investigator
Role Name Email Phone Fax
Principal Investigator Dr Tomas Hanke tomas.hanke@ndm.ox.ac.uk +44 (0)1865 617630 +44 (0)1865 617608
Street address City Postal code Country Position / Affiliation
ORCRB, Roosevelt Drive Oxford OX3 7DQ United Kingdom Head of HIV-1 vaccine group, Oxford University Research Lecturer, Jenner Institute Investigator