Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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] [2] 
[Units: Copies/ml]
Median (Inter-Quartile Range)
 NA [2]   NA [2]   39827 
 (1380 to 569000) 
 83628 
 (9660 to 750000) 
 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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
  Hide More Information

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 ( Registry Identifier: DAIDS ES Registry ID )
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