Clinical trial NCT02817451: DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants
Official title: Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Given as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and in HIV-Exposed Uninfected Infants in Republic of South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Polio
Human Immunodeficiency Virus Infection
Keywords: Diphtheria
Tetanus
Pertussis
Hepatitis B
DTaP IPV HB PRP-T Combined Vaccine
Human Immunodeficiency Virus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-06-29
Enrollment: 53
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to assess and confirm the adequate immunogenicity and safety profile of the Sanofi Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in HIV-exposed uninfected infants and in HIV-exposed infected infants.

The primary objectives of the study are:

* To evaluate the immunogenicity of the study vaccine 1 month after the 3-dose primary series in HIV-exposed infected and in HIV-exposed uninfected infants.
* To describe the persistence of all antibodies before receipt of the booster dose in HIV-exposed infected and in HIV-exposed uninfected infants.
* To evaluate the immunogenicity of the study vaccine 1 month after the booster dose in HIV-exposed infected and in HIV-exposed uninfected infants.

The secondary objectives of the study are:

* To describe the safety profile after each and all doses of the study vaccine administered as a 3-dose infant primary series in HIV-exposed infected and in HIV-exposed uninfected infants.
* To describe the safety profile of the study vaccine administered as a booster in HIV-exposed infected and in HIV-exposed uninfected infants.

Detailed description: Male and female infants born from HIV-infected mothers will be tested for HIV infection from birth to 6 weeks of age. HIV infected and HIV uninfected participants will be enrolled into two groups at Day 0. Some infants detected HIV-exposed infected outside of the hospital center facilities and the trial screening procedure may also be enrolled. All participants will receive primary vaccinations with Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age and a booster dose at approximately 15 to 18 months of age will receive a booster dose of the Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine.

Eligibility criteria: Inclusion Criteria:

(Screening Criteria for the participants mother)

* At least 18 years of age at the time of the Screening blood sample draw
* Self-reported or maternity-reported HIV infection in the mother

Inclusion Criteria:

* Born to an adult mother and aged 35 to 56 days (between 5 and 8 weeks of age) on the day of inclusion
* Group A participants must be HIV infected, as documented through the results of a polymerase chain reaction (PCR) test, and following an anti-retroviral therapy according to the national recommendations; and Group B participants must be HIV exposed uninfected infants, as documented through the results of a PCR test.
* Born with a birth weight ≥ 2.0 kg
* Informed consent form signed by the parent(s)/legal guardian(s) and by one independent witness if the parent(s)/legal guardian(s) is illiterate
* Participants and parent(s)/legal guardian(s) are able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* Participation in another clinical trial of an investigational product in the 4 weeks preceding the trial inclusion (receipt of study vaccine) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
* Group A participants diagnosed with a chronic condition, except HIV infection, or any experience of blood or blood-derived products received or experience of thrombocytopenia or bleeding disorder; and Group B participants diagnosed with chronic illness or any experience of blood or blood-derived products received or experience of thrombocytopenia or bleeding disorder.
* Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (oral polio vaccine \[OPV\] given at birth does not constitute an exclusion criteria), hepatitis B (a birth dose of Hep B vaccine does not constitute an exclusion criteria) diseases or Hib infection with the trial vaccine or another vaccine. Previous vaccination with Bacillus Calmette-Guerin (BCG) is not considered an exclusion criterion
* History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections (confirmed either clinically, serologically or microbiologically)
* History of seizures or history of uncontrolled neurologic disorder or uncontrolled epilepsy until treatment for the condition has been established, the condition has stabilized and the benefit clearly outweighs the risk
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
* Febrile (axillary temperature ≥ 38°C) or acute illness on the day of inclusion (temporary contraindication).

Primary outcomes:
measure: Number of Participants with Anti-Pertussis Toxoid (PT) and Anti-Filamentous Hemagglutinin (FHA) Antibody (Ab) Concentrations >= Lower Limit of Quantification (LLOQ) and >=4*LLOQ at Baseline
timeFrame: Day 0 (baseline)
measure: Geometric Means of Anti-Pertussis Toxoid and Anti-Filamentous Hemagglutinin Antibody Concentrations at Baseline
timeFrame: Day 0 (baseline)
measure: Geometric Means of Antibody Titers/Concentrations After Primary Series Vaccination
timeFrame: Day 90 (1 month after third dose)
measure: Number of Participants With Seroprotection After Primary Series Vaccination
timeFrame: Day 90 (1 month after third dose)
measure: Number of Participants with Vaccine Response or Seroconversion After Primary Series Vaccination
timeFrame: Day 0 (baseline), Day 90 (1 month after third dose)
measure: Geometric Means of Antibody Titers/Concentrations After Booster Vaccination
timeFrame: Day 420 (1 month after booster vaccination)
measure: Number of Participants With Seroprotection After Booster Vaccination
timeFrame: Day 420 (1 month after booster vaccination)
measure: Number of Participants With Vaccine Response or Seroconversion After Booster Vaccination
timeFrame: Day 0 (baseline), Day 420 (1 month after booster vaccination)
measure: Number of Participants With Booster Response After Booster Vaccination
timeFrame: Day 390 (pre-booster), Day 420 (1 month after booster dose)
Secondary outcomes:
measure: Number of Participants With Immediate Unsolicited Adverse Events (AE) After Primary Series Vaccination
timeFrame: Within 30 minutes after vaccination
measure: Number of Participants With Solicited Injections Site or Systemic Reactions After Primary Series Vaccination
timeFrame: Within 7 days after vaccination
measure: Number of Participants With Unsolicited Adverse Events After Primary Series Vaccination
timeFrame: Within 30 days after vaccination
measure: Number of Participants With Serious Adverse Events During the Study
timeFrame: Day 0 to Day 420
measure: Number of Participants With Immediate Unsolicited Adverse Events After Booster Vaccination
timeFrame: Within 30 minutes after booster vaccination
measure: Number of Participants With Solicited Injection Site or Systemic Reactions After Booster Vaccination
timeFrame: Within 7 days after booster vaccination
measure: Number of Participants With Unsolicited Adverse Events After Booster Vaccination
timeFrame: Within 30 days after booster vaccination
Other outcomes:
Locations:
city: Soweto
country: South Africa
Study officials:
affiliation: Sanofi Pasteur SA
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: