Safety and immunogenicity of a candidate HIV-1 vaccine, MVA.HIVA, administered to healthy infants born to HIV-1/2-infected mothers.

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR2009010001152787
• Date of registration: 10/12/2008
• Primary sponsor: Medical Research Council UK
• Public title: Safety and immunogenicity of a candidate HIV-1 vaccine, MVA.HIVA, administered to healthy infants born to HIV-1/2-infected mothers.
• 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
• Date of first enrolment: 2010-02-01
• Target sample size: 73
• Recruitment status: Closed to recruitment: follow up continuing
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2009010001152787
• Study type: interventional
• Study design: Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously,; Randomised,; Block randomisation is used.,; sealed envelopes,

Countries of recruitment

South Africa

Contacts

• Name: Tomas Hanke
• Affiliation: Head of HIV-1 vaccine group, Oxford University Research Lecturer, Jenner Institute Investigator

• Name: Tomas Hanke
• Affiliation: Head of HIV-1 vaccine group, Oxford University Research Lecturer, Jenner Institute Investigator

Key inclusion & exclusion criteria

Inclusion criteria: 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. b 18 years of age
d. Confirmation of HIV-1 infection documented by ELISA
e. CD4 count b 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 b 2500 grams
d. Born to an eligible woman
e. Written informed consent by parent

Exclusion criteria: 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.


Age minimum: 0 null
Age maximum: 3 null
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS
null

Primary Outcome(s)

Immunogenicity to MVA.HIVA

Safety and reactogenicity