Trial Outcomes & Findings for Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers (NCT NCT00880698)

Last Updated: 2021-11-05

Results Overview

Percentage of participants developing new grade \>=3 adverse events (abnormal laboratory values (hematology and chemistry), signs, symptoms and diagnoses) not present at the time of the first vaccination. Adverse events were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 1.0, December 2004, Clarification August 2009).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

202 participants

Primary outcome timeframe

From study entry until at least 42 days after third vaccination

Results posted on

2021-11-05

Participant Flow

Participants were recruited at five sites in four sub-saharan countries: Botswana (2), Tanzania, Zambia and Zimbabwe between December 2009 and October 2013.

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	62	64	37	39
Overall Study COMPLETED	61	61	36	36
Overall Study NOT COMPLETED	1	3	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Death	0	0	1	2
Overall Study Lost to Follow-up	1	3	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIV-uninfected RotaTeq n=62 Participants 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 n=64 Participants 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 n=37 Participants 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 n=39 Participants 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 n=202 Participants Total of all reporting groups
Age, Continuous	82 days n=5 Participants	79 days n=7 Participants	92 days n=5 Participants	93 days n=4 Participants	87 days n=21 Participants
Age, Customized 27-42 days	5 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants
Age, Customized 43-84 days	29 Participants n=5 Participants	39 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	88 Participants n=21 Participants
Age, Customized 85-105 days	28 Participants n=5 Participants	23 Participants n=7 Participants	26 Participants n=5 Participants	29 Participants n=4 Participants	106 Participants n=21 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	34 Participants n=7 Participants	19 Participants n=5 Participants	22 Participants n=4 Participants	108 Participants n=21 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	30 Participants n=7 Participants	18 Participants n=5 Participants	17 Participants n=4 Participants	94 Participants n=21 Participants
Region of Enrollment Botswana	19 participants n=5 Participants	18 participants n=7 Participants	17 participants n=5 Participants	16 participants n=4 Participants	70 participants n=21 Participants
Region of Enrollment Tanzania	3 participants n=5 Participants	4 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants	13 participants n=21 Participants
Region of Enrollment Zimbabwe	36 participants n=5 Participants	38 participants n=7 Participants	16 participants n=5 Participants	15 participants n=4 Participants	105 participants n=21 Participants
Region of Enrollment Zambia	4 participants n=5 Participants	4 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants	14 participants n=21 Participants
Ever breast fed Yes	36 participants n=5 Participants	43 participants n=7 Participants	22 participants n=5 Participants	26 participants n=4 Participants	127 participants n=21 Participants
Ever breast fed No	26 participants n=5 Participants	21 participants n=7 Participants	15 participants n=5 Participants	13 participants n=4 Participants	75 participants n=21 Participants
Screening CD4 percent (%)	37 percent n=5 Participants	38 percent n=7 Participants	31 percent n=5 Participants	29 percent n=4 Participants	35 percent n=21 Participants
HIV-1 RNA (copies/ml)	NA copies/ml n=5 Participants	NA copies/ml n=7 Participants	39827 copies/ml n=5 Participants	83628 copies/ml n=4 Participants	NA copies/ml n=21 Participants

PRIMARY outcome

Timeframe: From study entry until at least 42 days after third vaccination

Population: Participants classified 'as'randomized'. Includes all follow-up on participants unblinded during the study and found to be on RotaTeq. Follow-up on participants unblinded during the study and found to be on placebo censored at the time of their last study vaccination.

Outcome measures

Outcome measures
Measure	HIV-uninfected RotaTeq n=62 Participants 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 n=64 Participants 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 n=37 Participants 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 n=39 Participants 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
Percentage of Participants Developing New Grade >=3 Adverse Events	1.6 Percentage of participants Interval 0.0 to 8.7	4.7 Percentage of participants Interval 1.0 to 13.1	13.5 Percentage of participants Interval 4.5 to 28.8	12.8 Percentage of participants Interval 4.3 to 27.4

PRIMARY outcome

Timeframe: Prior to first vaccination and at least 14 days after third vaccination

Population: Only participants in the per-protocol population (received all 3 as-randomized vaccinations within recommended windows) and with measurements prior to the first vaccination and at least 11 days after the third vaccination and whose levels at the entry time point were less than one third of the upper limit of detection of the assay were included.

Percentage of participants who experienced \>=3-fold increases from prior to the first vaccination to at least 14 days after the third vaccination in Iga, SNA G1, SNA G2, SNA G3, SNA G4 and SNA P1.

Outcome measures

Outcome measures
Measure	HIV-uninfected RotaTeq n=57 Participants 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 n=58 Participants 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 n=34 Participants 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 n=32 Participants 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
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. SNA G1	31.6 Percentage of participants Interval 19.9 to 45.2	1.7 Percentage of participants Interval 0.0 to 9.2	52.9 Percentage of participants Interval 35.1 to 70.2	3.1 Percentage of participants Interval 0.1 to 16.2
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. SNA G2	12.3 Percentage of participants Interval 5.1 to 23.7	5.2 Percentage of participants Interval 1.1 to 14.4	23.5 Percentage of participants Interval 10.7 to 41.2	9.4 Percentage of participants Interval 2.0 to 25.0
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. SNA G3	21.1 Percentage of participants Interval 11.4 to 33.9	1.7 Percentage of participants Interval 0.0 to 9.2	29.4 Percentage of participants Interval 15.1 to 47.5	0.0 Percentage of participants Interval 0.0 to 10.9
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. SNA G4	31.6 Percentage of participants Interval 19.9 to 45.2	5.2 Percentage of participants Interval 1.1 to 14.4	61.8 Percentage of participants Interval 43.6 to 77.8	3.1 Percentage of participants Interval 0.1 to 16.2
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. SNA P1 (Uninfect Rot n=56; Infect Rot n=33)	25.0 Percentage of participants Interval 14.4 to 38.4	8.6 Percentage of participants Interval 2.9 to 19.0	24.2 Percentage of participants Interval 11.1 to 42.3	12.5 Percentage of participants Interval 3.5 to 29.0
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. IgA (Infect RotaTeq n=32; Placebo n=31)	80.7 Percentage of participants Interval 68.1 to 90.0	29.3 Percentage of participants Interval 18.1 to 42.7	81.3 Percentage of participants Interval 63.6 to 92.8	16.1 Percentage of participants Interval 5.5 to 33.7

SECONDARY outcome

Timeframe: At entry, days 7, 14, 21 and 42 days after first dose, and at days 7 and 21 after the second and third doses

Population: All participants 'as randomized'

Number of participants with at least one positive enzyme immuno assay (EIA) rotavirus antigen test, positive fluorescent focal assay, and specific for rotavirus gene 6 which codes for the VP6 protein after each vaccination.

Outcome measures

Outcome measures
Measure	HIV-uninfected RotaTeq n=62 Participants 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 n=64 Participants 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 n=37 Participants 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 n=39 Participants 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
Number of Participants With Fecal Shedding of RotaTeq Strains After Each Vaccination Post dose 1	0 participants	0 participants	1 participants	0 participants
Number of Participants With Fecal Shedding of RotaTeq Strains After Each Vaccination Post dose 2	0 participants	0 participants	0 participants	0 participants
Number of Participants With Fecal Shedding of RotaTeq Strains After Each Vaccination Post dose 3	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 42 days after third vaccination or last study visit with an HIV-1 RNA measurement

Population: Includes HIV-infected participants 'as-randomized' with an HIV-1 RNA measurement at their last study visit

Percentage of HIV-1 infected participants with HIV-1 RNA \<= 400 copies/ml at last study visit

Outcome measures

Outcome measures
Measure	HIV-uninfected RotaTeq n=35 Participants 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 n=34 Participants 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
Percentage of HIV-1 Infected Participants With HIV-1 RNA <= 400 Copies/ml	54.3 Percentage of participants	44.1 Percentage of participants	—	—

SECONDARY outcome

Timeframe: At entry and 42 days after third vaccination or last study visit with CD4 measurement

Population: Includes HIV-1 infected participants 'as-randomized' with a CD4 percent measurement prior to first vaccination and at last study visit

Change calculated as value at last study visit minus value closest to and before randomization date

Outcome measures

Outcome measures
Measure	HIV-uninfected RotaTeq n=36 Participants 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 n=35 Participants 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
Change in CD4 Percent From Entry to Last Study Visit in HIV-1 Infected Participants	3 Percentage of lymphocytes Standard Deviation 7.0	3 Percentage of lymphocytes Standard Deviation 8.7	—	—

SECONDARY outcome

Timeframe: At entry and 42 days after third vaccination or last study visit with CD4 measurement

Population: Includes HIV-infected participants 'as randomized' with a CD4 count measurement prior to first vaccination and at their last study visit

Change calculated as value at last study visit minus value closest to and before randomization date

Outcome measures

Outcome measures
Measure	HIV-uninfected RotaTeq n=36 Participants 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 n=35 Participants 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
Change in CD4 Count From Entry to Last Study Visit in HIV-1 Infected Participants	201 cells/mm^3 Standard Deviation 1060	335 cells/mm^3 Standard Deviation 1031	—	—

SECONDARY outcome

Timeframe: From study entry until at least 42 days after third vaccination

Population: Includes HIV-1 uninfected participants 'as-randomized' with an HIV test at entry and either 2 or 6 weeks after the third vaccination (or after the time point at which they would have received the third vaccination if they did not receive all three doses)

HIV tests were done at screening, entry and the last study visit after the third vaccination. Any participants classified as HIV-1 uninfected at screening or entry but HIV-1 infected at their last study visit would be classified as acquiring HIV-1 infection during the study

Outcome measures

Outcome measures
Measure	HIV-uninfected RotaTeq n=61 Participants 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 n=60 Participants 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
Number of Participants Classified at Screening or Entry as HIV-1 Uninfected, and Acquiring HIV-1 Infection on Study	0 participants	0 participants	—	—

Adverse Events

HIV-1 Uninfected RotaTeq

Serious events: 2 serious events

Other events: 39 other events

Deaths: 0 deaths

HIV-1 Uninfected Placebo

Serious events: 4 serious events

Other events: 39 other events

Deaths: 0 deaths

HIV-1 Infected RotaTeq

Serious events: 5 serious events

Other events: 29 other events

Deaths: 0 deaths

HIV-1 Infected Placebo

Serious events: 4 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HIV-1 Uninfected RotaTeq n=62 participants at risk	HIV-1 Uninfected Placebo n=64 participants at risk	HIV-1 Infected RotaTeq n=37 participants at risk	HIV-1 Infected Placebo n=39 participants at risk
Blood and lymphatic system disorders Anaemia	0.00% 0/62 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/64 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	2.7% 1/37 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/39 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.
Infections and infestations Gastroenteritis	3.2% 2/62 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	1.6% 1/64 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	2.7% 1/37 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	2.6% 1/39 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.
Infections and infestations Malaria	0.00% 0/62 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	1.6% 1/64 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/37 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/39 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.
Infections and infestations Measles	0.00% 0/62 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	1.6% 1/64 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/37 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/39 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.
Infections and infestations Pneumonia	0.00% 0/62 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/64 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	8.1% 3/37 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	5.1% 2/39 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.
Infections and infestations Pneumonia bacterial	0.00% 0/62 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/64 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/37 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	2.6% 1/39 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.
Injury, poisoning and procedural complications Overdose	0.00% 0/62 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	1.6% 1/64 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/37 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/39 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.
Nervous system disorders Febrile convulsion	0.00% 0/62 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/64 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/37 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	2.6% 1/39 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.
Skin and subcutaneous tissue disorders Rash	0.00% 0/62 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/64 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	0.00% 0/37 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.	2.6% 1/39 • From study enrollment until study completion (up to 24 weeks) The Serious Adverse Event (SAE) reporting category defined in V2.0 of the Division of AIDS (DAIDS) Expedited (EAE) Manual was used in addition to all cancers and vaccine overdoses. AEs were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0, Dec. 2004.

Other adverse events

Additional Information

Melissa Allen, Director, IMPAACT Operations Center

Family Health International (FHI 360)

Phone: (919) 405-1429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER