Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00981695
Other study ID # PV002
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received September 21, 2009
Last updated June 15, 2011
Start date November 2009
Est. completion date October 2011

Study information

Verified date September 2009
Source Medical Research Council
Contact Walter Jaoko, MB MTMed PhD
Phone +254-02-2717694
Email Wjaoko@kaviuon.org
Is FDA regulated No
Health authority Kenya: Ethical Review CommitteeKenya: Institutional Review BoardUnited States: Institutional Review BoardSweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

Objectives:

Primary: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants born to HIV-1-infected mothers.

Secondary:

- HIV-1 immunogenicity comparison between MVA.HIVA and age-matched unvaccinated control arms in each cohort (breastfeeding or formula feeding)

- HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants receiving MVA.HIVA

- HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants in the age-matched unvaccinated control group

- Comparison of responses to certain Kenyan Extended Programme on Immunization (KEPI) vaccines (OPV, DTP, HBV, and HiB) between MVA.HIVA versus age-matched unvaccinated controls in each cohort, between breast versus formula feeding infants in the age-matched unvaccinated control group, and between breast versus formula infants receiving MVA.HIVA

- Comparison of immune activation and phenotypic profile of lymphocytes between breast and formula feeding infants in each cohort (MVA.HIVA and age-matched unvaccinated control)

- Build capacity for Infant HIV-1 Vaccine Clinical Trials Centre in Nairobi, Kenya.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date October 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 3 Days
Eligibility Infant Inclusion Criteria

- Healthy infants

- < 3 days of age (day of birth = Day 0) at enrolment

- Birth weight > 2500 grams

- Born to an eligible woman

- Written informed consent by parent

Infant Exclusion Criteria

- HIV infection, as determined by a filter paper and/or RNA test prior to vaccination.

- Participation in any other HIV-1 vaccine or drug trial.

- Failure to receive all standard KEPI immunizations according to national immunization programme.

- Weight for age z-scores outside of 2 standard deviations of normal at the time of vaccination.

- 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).

- Axillary temperature of = 37.5 °C at the time of vaccination.

- Any clinically significant abnormal finding on screening from biochemistry or haematology by the time of vaccination.

- 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.

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Biological:
MVA.HIVA
1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly

Locations

Country Name City State
Kenya Kenyatta National Hospital Nairobi

Sponsors (2)

Lead Sponsor Collaborator
Medical Research Council European and Developing Countries Clinical Trials Partnership (EDCTP)

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary For safety and reactogenicity: Actively and passively collected data on adverse events. Up to 28 weeks after vaccination Yes
Secondary For immunogenicity to KEPI vaccines: Antibody levels to specific vaccines as measured by ELISA. 1 week before and 1 week after vaccination No
Secondary For immunogenicity to MVA.HIVA: Frequency of IFN-?-producing cells determined in an ELISPOT assay after overnight stimulation with a pool of HIVA-derived peptides. Up to 24 weeks after vaccination No
See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2