Safety and immunogenicity of live attenuated varicella vaccine in 9-month-old children
1Hacettepe University Faculty of Medicine, Pediatric Infectious Disease Unit, Ankara, Turkey. gkanra@gen.hun.edu.tr
Insights
This study shows that the live attenuated varicella vaccine (Oka-strain) is safe and effective in 9-month-old infants, demonstrating high seroconversion rates and minimal side effects. This finding supports its use in young children, particularly during varicella outbreaks.
Area of Science:
- Pediatric Vaccinology
- Immunology
- Public Health
Background:
- Evaluating the safety and immunogenicity of live attenuated varicella vaccine (Oka-strain).
- Focus on 9-month-old infants as the target population.
Purpose of the Study:
- To assess the safety profile of the varicella vaccine in infants.
- To determine the immunogenicity of the vaccine in this age group.
Main Methods:
- 114 infants received a single dose of live attenuated varicella vaccine (Valrix).
- Adverse events were monitored for 42 days post-vaccination.
- Varicella antibody levels were measured using indirect immunofluorescence.
Main Results:
- 47.4% of infants reported mild, transient symptoms; pain at injection site (28.1%) and fever (27.2%) were most common.
- No serious adverse events were reported; unsolicited symptoms were unrelated to vaccination.
- 97.1% seroconversion rate in initially seronegative infants, with a geometric mean titer of 30.9.
Conclusions:
- The varicella vaccine is safe and immunogenic in infants as young as 9 months.
- This vaccine can be clinically significant for managing varicella outbreaks.
- Potential benefits highlighted for developing countries with high varicella incidence.
Background:
The present study was conducted to evaluate the safety and immunogenicity of live attenuated varicella vaccine (Oka-strain) in 9-month-old infants.
Methods:
One hundred and fourteen infants were vaccinated once with live attenuated varicella vaccine (Valrix; SmithKline Beecham Biologicals, Rixensart, Belgium) containing a mean virus titer of 10(4.0) plaque-forming units (p.f.u.) per dose. Signs and/or symptoms after vaccination were followed for 42 days. Home visits were made to detect solicited local reactions (0-3 days) and solicited general reactions (0-21 days), as well as unsolicited reactions. Specific varicella antibodies were determined by an indirect immunofluorescence method. The geometric mean titer and seroconversion rate were calculated.
Results:
Signs and/or symptoms were reported in 47.4% (54/114) of cases following vaccination. The only local symptom reported was pain on digital pressure at the injection site and this was reported in 28.1% (32/114) of infants. General symptoms were reported in 38.6% (44/114) of cases. The most frequently reported findings were fever (27.2%), which was mostly mild, restlessness (20.2%) and cough (11.4%). Only four unsolicited symptoms were reported and they were all unrelated to vaccination. No serious adverse event was reported. Of the 109 infants included in the immunogenicity analysis, 105 were seronegative and four were seropositive for antibodies against varicella before vaccination. The vaccine elicited seroconversion in 97.1% of initially seronegative cases. The post-vaccination geometric mean titer for these infants was 30.9 geometric mean titer (GMT).
Conclusions:
The vaccine was found to be safe and immunogenic when given to infants as young as 9 months of age. This may be of clinical significance during outbreaks of varicella and especially for developing countries.
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