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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.: PACTR2009010001152787 Date registered: 2008/12/10
TRIAL DESCRIPTION
Public title Safety and immunogenicity of a candidate HIV-1 vaccine, MVA.HIVA, administered to healthy infants born to HIV-1/2-infected mothers.
Official scientific title An open randomized phase I/II study evaluating safety and immunogenicity of a candidate HIV-1 vaccine, MVA.HIVA, administered to healthy infants born
Brief summary describing the background
and objectives of the trial
This is an open randomized phase I/II study of a candidate HIV vaccine, MVA.HIVA, in healthy infants born to HIV-1 infected mothers. The immunology lab will be blinded for the investigational product/placebo allocation Primary objective: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants born to HIV-1-infected mothers.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PV002
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Prevention
Anticipated trial start date 2010-02-01
Actual trial start date 2010-02-01
Anticipated date of last follow up 2012-05-01
Actual date of last follow up
Anticipated target sample size (number of participants) 72   
Actual target sample size (number of participants) 73   
Recruitment status Closed to recruitment: follow up complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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 Block randomisation is used. 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 36 Uncontrolled
Experimental group MVA.HIVA 5x10^7 5x10^7 pfu of MVA.HIVA intramuscularly 36 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Mother Inclusion Criteria a. Second or third trimester of pregnancy, as determined by a clinical exam and reported menstrual history b. Written informed consent c. > 18 years of age d. Confirmation of HIV-1 infection documented by ELISA e. CD4 count > 350 cells/ ¿l in the screening blood specimen and at 6 weeks after delivery f. Stated willingness to receive HAART during pregnancy and breastfeeding (if applicable) g. Stated intent to deliver at Kenyatta National Hospital h. Stated intent to remain in the Nairobi area for at least a year after delivery Infant Inclusion Criteria a. Healthy infants b. < 3 days of age (day of birth = Day 0) at enrolment c. Birth weight > 2500 grams d. Born to an eligible woman e. Written informed consent by parent Mother Exclusion Criteria a. WHO stage 3 or 4 disease progression as determined by clinical evaulation b. Prior participation in any HIV-1 vaccine or drug trial c. Receipt of any investigational agent during this pregnancy d. Receipt of blood products, immunoglobulin, or immunotherapy during this pregnancy e. Evidence of clinically significant disease that would compromise the ability of the participant to complete the study or the study requirements as determined by the study clinician f. Known multiple gestation in the current pregnancy Infant Exclusion Criteria a. HIV infection, as determined by a filter paper and/or RNA test prior to vaccination. b. Participation in any other HIV-1 vaccine or drug trial. c. Failure to receive all standard KEPI immunizations according to national immunization programme (Table 5). d. Weight for age z-scores outside of 2 standard deviations of normal at the time of vaccination. e. 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., temperature of <37.5 °C). f. Axillary temperature of ¿ 37.5 °C at the time of vaccination. g. Any clinically significant abnormal finding on screening from biochemistry or haematology by the time of vaccination. h. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g., egg products. i. Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine. j. Any other on-going chronic illness requiring hospital specialist supervision. k. Administration of immunoglobulins and/or any blood products within one month preceding the planned administration of the vaccine candidate. l. Any history of anaphylaxis in reaction to vaccination. m. 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. n. Likelihood of travel away from the study area. 0 null 3 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 2008/11/27 Oxford Tropical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Manor House, JR Hospital Oxford OX3 9DZ 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 2011/06/14 Kenyatta National Hospital Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 19676 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 2011/02/11 University of Washington Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UoW office of research Seattle Box 355753 United States of America

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Safety and reactogenicity Actively and passively collected data on adverse events
Primary Outcome Immunogenicity to MVA.HIVA Infant age 19, 21, 28, 36 and 48 weeks

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta National Hospital Ngong Road Nairobi 00202 Kenya

FUNDING SOURCES
Name of source Street address City Postal code Country

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
Marie Reilly Nobels väg 12A Stockholm SE-17177 Sweden
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
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
Marie Reilly Nobels väg 12A Stockholm SE-17177 Sweden
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
Katie Flanagan MRC Laboratories, PO Box 273 Fajara Gambia

CONTACT PEOPLE
Role Name Email Phone Fax
Public Enquiries Dr Tomas Hanke tomas.hanke@ndm.ox.ac.uk +44 1865 617630 +44 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
Scientific Enquiries Dr Tomas Hanke tomas.hanke@ndm.ox.ac.uk +44 1865 617630 +44 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 1865 617630 +44 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