Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00880698
First received: April 10, 2009
Last updated: July 17, 2015
Last verified: July 2015
Results First Received: June 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infection
Rotavirus Infection
Interventions: Biological: RotaTeq
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at five sites in four sub-saharan countries: Botswana (2), Tanzania, Zambia and Zimbabwe between December 2009 and October 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrollment of infants 2 to < 15 weeks of age was stratified by HIV-1 infection and within the HIV-1 infected stratum, by CD4% (<15%, 15%-<20% and >=20%). Within stratum, participants were randomized with equal probability to receive three doses of RotaTeq or Placebo.

Reporting Groups
  Description
HIV-uninfected RotaTeq

HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.

RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose

HIV-uninfected Placebo

HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age

Placebo: 2 mL solution

HIV-infected RotaTeq

HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.

RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose

HIV-1 Infected Placebo

HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age

Placebo: 2 mL solution


Participant Flow:   Overall Study
    HIV-uninfected RotaTeq     HIV-uninfected Placebo     HIV-infected RotaTeq     HIV-1 Infected Placebo  
STARTED     62     64     37     39  
COMPLETED     61     61     36     36  
NOT COMPLETED     1     3     1     3  
Death                 0                 0                 1                 2  
Lost to Follow-up                 1                 3                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all participants 'as randomized'

Reporting Groups
  Description
HIV-uninfected RotaTeq

HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.

RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose

HIV-uninfected Placebo

HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age

Placebo: 2 mL solution

HIV-infected RotaTeq

HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.

RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose

HIV-1 Infected Placebo

HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age

Placebo: 2 mL solution

Total Total of all reporting groups

Baseline Measures
    HIV-uninfected RotaTeq     HIV-uninfected Placebo     HIV-infected RotaTeq     HIV-1 Infected Placebo     Total  
Number of Participants  
[units: participants]
  62     64     37     39     202  
Age  
[units: days]
Median (Inter-Quartile Range)
  82   (71 to 92)     79   (71 to 92)     92   (82 to 94)     93   (83 to 99)     87   (75 to 94)  
Age, Customized  
[units: Participants]
         
27-42 days     5     2     1     0     8  
43-84 days     29     39     10     10     88  
85-105 days     28     23     26     29     106  
Gender  
[units: participants]
         
Female     33     34     19     22     108  
Male     29     30     18     17     94  
Region of Enrollment  
[units: participants]
         
Botswana     19     18     17     16     70  
Tanzania     3     4     2     4     13  
Zimbabwe     36     38     16     15     105  
Zambia     4     4     2     4     14  
Ever breast fed  
[units: participants]
         
Yes     36     43     22     26     127  
No     26     21     15     13     75  
Screening CD4 percent (%)  
[units: percent]
Median (Inter-Quartile Range)
  37   (33 to 45)     38   (31 to 45)     31   (24 to 38)     29   (23 to 34)     35   (28 to 43)  
HIV-1 RNA (copies/ml) [1]
[units: copies/ml]
Median (Inter-Quartile Range)
  NA   (NA to NA) [2]   NA   (NA to NA) [2]   39827   (1380 to 569000)     83628   (9660 to 750000)     NA   (NA to NA) [2]
[1] HIV-1 RNA not collected in HIV-1 uninfected stratum. HIV-1 infected RotaTeq (n=35), Placebo (n=37). Upper limit of detection of HIV-1 RNA assay is 750,000 copies/ml.
[2] Not collected in HIV-1 uninfected cohort



  Outcome Measures
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1.  Primary:   Percentage of Participants Developing New Grade >=3 Adverse Events   [ Time Frame: From study entry until at least 42 days after third vaccination ]

2.  Primary:   Percentage of Participants Classified as Responders as Measured by Serum Anti-rotavirus IgA ELISA (IgA) and Serum Neutralizing Antibodies (SNA) G1, G2, G3, G4 and P1.   [ Time Frame: Prior to first vaccination and at least 14 days after third vaccination ]

3.  Secondary:   Number of Participants With Fecal Shedding of RotaTeq Strains After Each Vaccination   [ Time Frame: At entry, days 7, 14, 21 and 42 days after first dose, and at days 7 and 21 after the second and third doses ]

4.  Secondary:   Percentage of HIV-1 Infected Participants With HIV-1 RNA <= 400 Copies/ml   [ Time Frame: 42 days after third vaccination or last study visit with an HIV-1 RNA measurement ]

5.  Secondary:   Change in CD4 Percent From Entry to Last Study Visit in HIV-1 Infected Participants   [ Time Frame: At entry and 42 days after third vaccination or last study visit with CD4 measurement ]

6.  Secondary:   Change in CD4 Count From Entry to Last Study Visit in HIV-1 Infected Participants   [ Time Frame: At entry and 42 days after third vaccination or last study visit with CD4 measurement ]

7.  Secondary:   Number of Participants Classified at Screening or Entry as HIV-1 Uninfected, and Acquiring HIV-1 Infection on Study   [ Time Frame: From study entry until at least 42 days after third vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was closed to enrollment prematurely so statistical power to detect differences was reduced.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
phone: (919) 405-1429
e-mail: mallen@fhi360.org


Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00880698     History of Changes
Other Study ID Numbers: P1072, 10638, IMPAACT P1072
Study First Received: April 10, 2009
Results First Received: June 22, 2015
Last Updated: July 17, 2015
Health Authority: United States: Food and Drug Administration