Safety and immune responses following administration of H1N1 live attenuated influenza vaccine in Thais

Phonrat, Benjaluck; Pitisuttithum, Punnee; Chamnanchanunt, Supat; Puthavathana, Pilaipan; Ngaosuwankul, Nathamon; Louisirirotchanakul, Suda; Dhitavat, Jittima; Thirapakpoomanunt, Sit; Chokevivat, Vichai; Wibulpolprasert, Suwit

doi:10.1016/j.vaccine.2012.12.082

Cited by 12 publications

(18 citation statements)

References 34 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Participants were healthy Thai men and women aged 18–49 years with an antibody titre to specific H5 influenza virus of less than 1/40 by haemagglutination inhibition. Characteristics of participants were similar to those reported previously 11, 17. Breastfeeding mothers, pregnant women, and women who planned to become pregnant within 60 days of enrolment were excluded from the study.…”

Section: Methodsmentioning

confidence: 95%

“…We measured IgG and IgA antibodies in serum samples and in nasal wash samples by ELISA, as described previously, 17 using recombinant H5N1 proteins (obtained from National Institute for Biological Standards and Control, UK). Positive IgA was established based on the cutoff value (optical density ≥0.2) established from the average optical density values obtained from the prevaccination samples plus 3 SD.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Safety and immunogenicity of a live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 H5N2 and its priming effects for potential pre-pandemic use: a randomised, double-blind, placebo-controlled trial

Pitisuttithum

Boonnak

Chamnanchanunt

et al. 2017

The Lancet Infectious Diseases

Self Cite

View full text Add to dashboard Cite

SummaryBackgroundThe emergence of highly pathogenic avian influenza H5N1 viruses has raised concerns about their pandemic potential. Vaccination is the most effective way of preventing influenza. In this study, we investigated the safety and immunogenicity of an avian H5N2 live attenuated influenza vaccine (LAIV H5N2) in healthy Thai adults and its priming immune responses with an H5N1 inactivated vaccine boost.MethodsThis study was done at the Vaccine Trial Centre at Mahidol University, Bangkok, Thailand and was divided into two parts. Part 1 consisted of a randomised, double-blind, placebo-controlled trial done over 18 months. We randomly assigned (2:1) healthy Thai adults aged 18–49 years with a computer generated randomisation sequence (blocks of six) to receive either two intranasal doses (0·25 mL per nostril) of LAIV H5N2 (101 participants) or placebo (51 participants) 21 days apart. For part 2, an open-label trial was done in which previously vaccinated participants (40 from LAIV H5N2 group and 20 placebo) were given one intramuscular dose (0·5 mL) of H5N1 booster vaccine. Participants, investigators, and site-study workers were blinded from randomisation. Immune responses after subsequent immunisation were evaluated using haemagglutination-inhibition and microneutralisation assays and circulating follicular T-helper cells and plasmablast cells were measured in serum and whole blood. The trials are registered with ClinicalTrials.gov, numbers NCT01841918 and NCT02229357.FindingsBetween Feb 4, 2013, and Feb 28, 2013, 256 individuals were screened, of whom 152 participants were enrolled in part 1 of this study. LAIV H5N2 vaccine was well tolerated. Viral shedding was detected in only six (6%) of 101 participants in the vaccine group 1 day after the first vaccination and in and two (2%) of 98 participants in the group after the second vaccination. There was no serious adverse event in both groups. 51 (50%) of 101 participants in the vaccine group and 28 (55%) of 51 in the placebo group reported at least one adverse event. 80 (84%) of 95 events in the vaccine group and 32 (78%) of 43 events in the placebo groups were reportedly suspected adverse events, probably related to the vaccine; however, most were mild in nature. After two doses of vaccine, 13 (13%) of 100 participants in the vaccine group had an increase in haemagglutination-inhibition titre of more than four-fold and four (4%) of 100 vaccinees developed a rise in neutralisng antibody titre of more than four-fold. 1 year later, after a booster with an inactivated H5N1 vaccine (part 2), 39 (98%) of 40 participants who had previously been vaccinated with LAIV H5N2 had an increase in haemagglutination-inhibition titre of greater than four-fold as early as day 7 compared with three (15%) of 20 participants in the placebo group. Peak geometric mean titre (GMT) for haemagglutination-inhibition antibodies in the previously LAIV H5N2 vaccinated group (566·89 [95% CI 436·97–735·44]) were significantly higher than among those who previously received placebo (25·4...

show abstract

Section: Methodsmentioning

confidence: 95%

Section: Methodsmentioning

confidence: 99%

Safety and immunogenicity of a live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 H5N2 and its priming effects for potential pre-pandemic use: a randomised, double-blind, placebo-controlled trial

Pitisuttithum

Boonnak

Chamnanchanunt

et al. 2017

The Lancet Infectious Diseases

Self Cite

View full text Add to dashboard Cite

show abstract

“…Using LAIV production technology adapted from IEM, GPO successfully produced H1N1pdm09 LAIV, conducted preclinical and clinical trials of this vaccine, and registered it in 2011 [21]. Since the registration of H1N1pdm09 LAIV, intensive studies of another pre-pandemic LAIV candidate – H5N2 – have been carried out at GPO.…”

Section: Progress Of Development Of Laiv In the Nicsmentioning

confidence: 99%

Development and approval of live attenuated influenza vaccines based on Russian master donor viruses: Process challenges and success stories

Rudenko

Yeolekar

Kiseleva

et al. 2016

Vaccine

View full text Add to dashboard Cite

show abstract

“…Based on the WHO recommendations for production and quality control of LAIV, the GMP-certified pilot plant was built at Silapakorn University in Bangkok, Thailand. 8 Some initial obstacles were encountered such as a lower yield of doses than expected, the need to import a huge number of specific pathogen-free (SPF) eggs and longer time for the optimization processes. 9 The H1N1 monovalent vaccine was shown to be safe and immunogenic, fulfilling the criteria for licensure for emergency use.…”

mentioning

confidence: 99%

“…9 The H1N1 monovalent vaccine was shown to be safe and immunogenic, fulfilling the criteria for licensure for emergency use. 8 GPO-manufactured live attenuated influenza H5 candidate vaccine GPO had received master donor seed H5N2 candidate vaccine strain (A/17/turkey/Turkey/05/133) from WHO. The product was assessed in preclinical and nonclinical studies and then moved to a phase I clinical trial.…”

mentioning

confidence: 99%

A review of epidemic preparedness for influenza through local vaccine production: national security for Thailand

Pitisuttithum

Wirachwong

2019

Human Vaccines & Immunotherapeutics

Self Cite

View full text Add to dashboard Cite

Being vigilant of the potential for an influenza pandemic, the Global Action Plan for Influenza Vaccines (GAP) promoted the establishment and maintenance of local vaccine manufacturing capacity. In accordance with this, the Thai government has developed its national strategic plan for influenza pandemic preparedness including the plan for manufacturing influenza vaccine in Thailand. With the support of WHO, the Thai Government Pharmaceutical Organization (GPO) as the developed local production capacity of influenza vaccines. The H1N1 live attenuated influenza vaccine (LAIV) and H5N2 LAIV produced by GPO have been proven to be safe and immunogenic through clinical trials, followed by Thai FDA licensure for pandemic use. The GPO-produced H5N2 LAIV has been proven to have priming effects on an inactivated subunit H5N1 booster vaccine. This Thai local manufacturer is now expanding its capacity to Inactivated Influenza Vaccine (IIV), aiming for sustainable influenza vaccine production for national coverage.

show abstract

Safety and immune responses following administration of H1N1 live attenuated influenza vaccine in Thais

Cited by 12 publications

References 34 publications

Safety and immunogenicity of a live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 H5N2 and its priming effects for potential pre-pandemic use: a randomised, double-blind, placebo-controlled trial

Safety and immunogenicity of a live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 H5N2 and its priming effects for potential pre-pandemic use: a randomised, double-blind, placebo-controlled trial

Development and approval of live attenuated influenza vaccines based on Russian master donor viruses: Process challenges and success stories

A review of epidemic preparedness for influenza through local vaccine production: national security for Thailand

Contact Info

Product

Resources

About