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The safety and immunogenicity of trivalent inactivated influenza vaccination: a study of maternal-cord blood pairs in Taiwan.

Lin SY, Wu ET, Lin CH, Shyu MK, Lee CN - PLoS ONE (2013)

Bottom Line: There are little data about adverse effects and immunogenicity of flu vaccine in Asian pregnant women.No significant adverse effects were detected.Trivalent flu vaccine induces a strong immune response in pregnant women and their infants without adverse effects.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, National Taiwan University Hospital, Hsin Chu branch, Hsin Chu, Taiwan.

ABSTRACT

Background: There are little data about adverse effects and immunogenicity of flu vaccine in Asian pregnant women.

Methods: This prospective trial (NCT01514708) enrolled 46 pregnant women who received a single intramuscular dose of trivalent flu vaccine (AdimFlu-S®) containing 15 mcg of hemagglutinin for each strain/0.5 mL from influenza A (H1N1), influenza A (H3N2), and influenza B after the first trimester. Blood samples were collected at day 0 and 28 after vaccination, and at delivery. Cord blood was also collected. Hemagglutination inhibition (HAI) assays were performed to determine seroprotection and seroconversion rates and fold increase in the HAI geometric mean titer (GMT).

Results: Twenty-eight days after vaccination the seroprotection rate against H1N1, H3N2, and influenza B was 91.3%, 84.8% and 56.5%, respectively. The GMT fold increase was 12.8, 8.4, and 4.6 for H1N1, H3N2, and influenza B, respectively. At delivery, both the seroprotection rate (86.4%, 68.2%, and 47.7%) and GMT fold increase (9.4, 5.7 and 3.8) were slightly lower than day 28. The seroprotection rate and GMT fold increase in maternal and cord blood samples were comparable. No significant adverse effects were detected.

Conclusions: Trivalent flu vaccine induces a strong immune response in pregnant women and their infants without adverse effects.

Trial registration: Clinical Trials. gov NCT01514708.

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Related in: MedlinePlus

The trial profiles.
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pone-0062983-g001: The trial profiles.

Mentions: A total of 46 subjects with singleton pregnancies were enrolled, had baseline serology testing, and received the vaccination (Figure 1). Two subjects withdrew from the study after vaccination, and cord blood samples were not obtained from 2 subjects because they did not deliver the baby at the assigned hospital. The demographic, clinical, and obstetric characteristics of all 46 vaccinated pregnant subjects are summarized in Table 1. The mean age of the subjects was 33.0 years and the mean body mass index (BMI) was 25.3 kg/m2. None of the subjects reported a drinking history and 45 (97.8%) denied a history of smoking. Twenty-eight subjects (60.9%) reported symptoms of an illness within the prior 3 months, and the most commonly reported was abdominal pain (10.9%). In addition, 11 subjects (23.9%) had at least 1 concurrent medical condition. The mean gestational age at which the vaccine was administered was 29.0 weeks.


The safety and immunogenicity of trivalent inactivated influenza vaccination: a study of maternal-cord blood pairs in Taiwan.

Lin SY, Wu ET, Lin CH, Shyu MK, Lee CN - PLoS ONE (2013)

The trial profiles.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3675132&req=5

pone-0062983-g001: The trial profiles.
Mentions: A total of 46 subjects with singleton pregnancies were enrolled, had baseline serology testing, and received the vaccination (Figure 1). Two subjects withdrew from the study after vaccination, and cord blood samples were not obtained from 2 subjects because they did not deliver the baby at the assigned hospital. The demographic, clinical, and obstetric characteristics of all 46 vaccinated pregnant subjects are summarized in Table 1. The mean age of the subjects was 33.0 years and the mean body mass index (BMI) was 25.3 kg/m2. None of the subjects reported a drinking history and 45 (97.8%) denied a history of smoking. Twenty-eight subjects (60.9%) reported symptoms of an illness within the prior 3 months, and the most commonly reported was abdominal pain (10.9%). In addition, 11 subjects (23.9%) had at least 1 concurrent medical condition. The mean gestational age at which the vaccine was administered was 29.0 weeks.

Bottom Line: There are little data about adverse effects and immunogenicity of flu vaccine in Asian pregnant women.No significant adverse effects were detected.Trivalent flu vaccine induces a strong immune response in pregnant women and their infants without adverse effects.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, National Taiwan University Hospital, Hsin Chu branch, Hsin Chu, Taiwan.

ABSTRACT

Background: There are little data about adverse effects and immunogenicity of flu vaccine in Asian pregnant women.

Methods: This prospective trial (NCT01514708) enrolled 46 pregnant women who received a single intramuscular dose of trivalent flu vaccine (AdimFlu-S®) containing 15 mcg of hemagglutinin for each strain/0.5 mL from influenza A (H1N1), influenza A (H3N2), and influenza B after the first trimester. Blood samples were collected at day 0 and 28 after vaccination, and at delivery. Cord blood was also collected. Hemagglutination inhibition (HAI) assays were performed to determine seroprotection and seroconversion rates and fold increase in the HAI geometric mean titer (GMT).

Results: Twenty-eight days after vaccination the seroprotection rate against H1N1, H3N2, and influenza B was 91.3%, 84.8% and 56.5%, respectively. The GMT fold increase was 12.8, 8.4, and 4.6 for H1N1, H3N2, and influenza B, respectively. At delivery, both the seroprotection rate (86.4%, 68.2%, and 47.7%) and GMT fold increase (9.4, 5.7 and 3.8) were slightly lower than day 28. The seroprotection rate and GMT fold increase in maternal and cord blood samples were comparable. No significant adverse effects were detected.

Conclusions: Trivalent flu vaccine induces a strong immune response in pregnant women and their infants without adverse effects.

Trial registration: Clinical Trials. gov NCT01514708.

Show MeSH
Related in: MedlinePlus