Related Experiment Videos
Symptoms associated with rhesus-human reassortant rotavirus vaccine in infants
J Joensuu1, E Koskenniemi, T Vesikari
1University of Tampere, Medical School, Finland.
Insights
The first dose of the rhesus-human reassortant tetravalent (RRV-TV) vaccine can cause fever and other reactions in infants. Subsequent doses showed fewer adverse events, indicating a generally safe vaccine profile.
Area of Science:
- Pediatrics
- Vaccinology
- Infectious Diseases
Background:
- Rotavirus gastroenteritis poses a significant health risk to children.
- The rhesus-human reassortant tetravalent (RRV-TV) vaccine offers potential prevention against severe rotavirus infections.
- The RRV-TV vaccine was being considered for licensure in the US and Europe.
Purpose of the Study:
- To assess the safety and symptoms associated with the high-titer RRV-TV vaccine.
- To evaluate adverse events when RRV-TV vaccine is administered with routine childhood immunizations.
Main Methods:
- A randomized, placebo-controlled, double-blind trial involving 2282 children.
- Participants received three doses of RRV-TV vaccine (4 x 10(5) PFU) or placebo between 2 and 7 months of age.
- Parents monitored and recorded symptoms, including daily rectal temperatures.
Main Results:
- The first RRV-TV dose was linked to a higher incidence of fever (38.0°C+) (33% vs. 2.3%) and higher fever (39.0°C+) (3.4% vs. 0.2%) compared to placebo.
- Increased irritability, decreased appetite, and abdominal cramping were more common post-first dose in the RRV-TV group.
- One RRV-TV recipient was hospitalized within 5 days of the first dose, with minor differences observed after second and third doses.
Conclusions:
- The initial dose of RRV-TV vaccine is associated with a notable rate of febrile and other reactions.
- These reactions may necessitate medical attention and, in rare instances, hospitalization.
- The safety profile appears manageable, particularly after the first dose.
Background:
Severe rotavirus gastroenteritis is potentially preventable by oral rhesus-human reassortant tetravalent (RRV-TV) vaccine, which may soon be licensed in the US and Europe. The objective of this study was to evaluate symptoms associated with the high titer RRV-TV vaccine given concurrently with routine childhood immunizations.
Methods:
In a randomized placebo-controlled double blind trial of RRV-TV vaccine titer 4 x 10(5) plaque-forming units vs. placebo, 2282 children received all 3 doses of study vaccine between ages 2 and 7 months. Symptoms were followed by parents who also took daily rectal temperatures.
Results:
On Days 3 to 5 after the first dose of vaccine fever 38.0 degrees C or greater was detected in 387 of 1182 (33%) infants in the RRV-TV vaccine group vs. 27 of 1194 (2.3%) infants in the placebo group (P < 0.001) and fever 39.0 degrees C or greater was detected in 40 (3.4%) and 3 (0.2%) infants in the vaccine and placebo groups, respectively (P < 0.001). Irritability, decreased appetite and abdominal cramping on Days 3 to 5 postvaccination were also more common in the RRV-TV vaccine recipients than in the placebo recipients. One child in the RRV-TV group was hospitalized and 2 more infants seen in the clinic, vs. none in the placebo group, within the 5-day period after the first dose for a reason probably related to the RRV-TV vaccine. After the second and third doses of RRV-TV vaccine, there were only minor differences between the vaccine and placebo recipients in fever on Days 3 to 5 postvaccination.
Conclusions:
The first dose of RRV-TV vaccine is associated with a relatively high rate of febrile and other reactions, which may require a physician visit and, rarely, hospitalization.