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.: PACTR2009010001152787 Date of Approval: 12/10/2009
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-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 Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/02/2010
Actual trial start date 01/02/2010
Anticipated date of last follow up 01/05/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 73
Recruitment status Completed
Publication URL http://dx.doi.org/10.1016/j.vaccine.2014.08.034
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 Block randomisation is used. sealed envelopes Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Block randomisation is used. 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 36 Uncontrolled
Experimental Group MVA.HIVA 5x10^7 5x10^7 pfu of MVA.HIVA intramuscularly 36 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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. 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 27/11/2008 Oxford Tropical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Services, University of Oxford, Boundary Brook House, Churchill Drive Oxford OX3 7GB 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 08/04/2009 Kenyatta National Hospital Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 20723 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 01/10/2009 University of Washington Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Box 359470 UoW Human Subjects Division Seattle 981959470 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Safety and reactogenicity Infant age 19, 21, 28, 36 and 48 weeks
Primary Outcome Immunogenicity to MVA.HIVA Infant age 19, 21, 28, 36 and 48 weeks
Secondary Outcome Determination of gross interference of MVA.HIVA with the immunogenicity of DTwPHib, HepB, OPV and PCV-7 vaccines through comparing actively collected data on antibody levels to the antigens contained in these EPI vaccines in the vaccine and control groups. Infant age 19 and 21 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
European and developing countries clinical trials partnership Anna van Saksenlaan, 51-2593 HW The Hague 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
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
Marie Reilly Nobels väg 12A Stockholm SE-17177 Sweden
Marie Reilly Nobels väg 12A Stockholm SE-17177 Sweden
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
Katie Flanagan MRC Laboratories, PO Box 273 Fajara Gambia
Katie Flanagan MRC Laboratories, PO Box 273 Fajara Gambia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tomas Hanke tomas.hanke@ndm.ox.ac.uk +44 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 +44 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
Scientific Enquiries Tomas Hanke tomas.hanke@ndm.ox.ac.uk +44 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 giving results is available at http://dx.doi.org/10.1016/j.vaccine.2014.08.034. 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 on request scientific merit
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://dx.doi.org/10.1016/j.vaccine.2014.08.034 Yes 12/08/2024 07/10/2014
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 http://dx.doi.org/10.1016/j.vaccine.2014.08.034
Changes to trial information