Clinical trial NCT00982579: Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers
Official title: An Open Randomized Phase I Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1/2-uninfected Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV-1
HIV Infections
Keywords: HIV preventive vaccine
Lead sponsor: Medical Research Council
Sponsor class: OTHER_GOV
Collaborators: name: European and Developing Countries Clinical Trials Partnership (EDCTP)
First posted: 2009-09-23
Enrollment: 48
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objectives:

Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers.

Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV) when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine within the first 4 weeks of life.


Eligibility criteria: Inclusion Criteria:

* Healthy infants, 19 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-1/2-uninfected.

Exclusion Criteria:

* 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 19 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.
* Any other clinical evidence of infection.

Primary outcomes:
measure: For safety and reactogenicity: Actively and passively collected data on adverse events
timeFrame: Up to 16 weeks after vaccination
Secondary outcomes:
measure: For immunity to EPI vaccines: Antibody levels to specific vaccines.
timeFrame: 1 week before and 1 week after vaccination
measure: For immunogenicity: Frequency of IFN-γ producing cells determined in ex-vivo (effector) and 10-day cultured (memory) ELISPOT assays after overnight stimulation with pools of HIVA-derived peptides
timeFrame: Up to 16 weeks after vaccination
Other outcomes:
Locations:
city: Banjul
country: Gambia
facility: Medical Research Council Laboratories, The Gambia
state: Fajara
Study officials:
affiliation: Medical Research Council
name: Tomas Hanke
role: STUDY_DIRECTOR
affiliation: Medical Research Council, The Gambia
name: Katie Flanagan
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Marie Reilly
role: PRINCIPAL_INVESTIGATOR
References:
citation: Afolabi MO, Ndure J, Drammeh A, Darboe F, Mehedi SR, Rowland-Jones SL, Borthwick N, Black A, Ambler G, John-Stewart GC, Reilly M, Hanke T, Flanagan KL. A phase I randomized clinical trial of candidate human immunodeficiency virus type 1 vaccine MVA.HIVA administered to Gambian infants. PLoS One. 2013 Oct 24;8(10):e78289. doi: 10.1371/journal.pone.0078289. eCollection 2013.