A randomized, dose-ranging assessment of the immunogenicity and safety of a booster dose of a combined diphtheria-tetanus-whole cell pertussis-hepatitis B-inactivated poliovirus-<i><i>Hemophilus influenzae</i></i>type b (DTPw-HBV-IPV/Hib) vaccine vs. co-administration of DTPw-HBV/Hib and IPV vaccines in 12 to 24 months old Filipino toddlers

Quiambao, Beatriz P.; Meeren, Olivier Van Der; Kolhe, Devayani; Gatchalian, Salvacion

doi:10.4161/hv.18630

Cited by 12 publications

(13 citation statements)

References 8 publications

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“…The seroconversion rates after two doses 1/10 IPV-Al were also considerably higher than those previously reported for two doses non-adjuvanted 1/5 IPV administered intradermally at 6 and 10 weeks 9, 11. Non-adjuvanted 1/5 IPV appears to perform very well when given as two intradermal doses at older ages (eg, 4 months and 8 months) or with larger dose intervals (eg, 4 months),9, 12, 14 or given as one intramuscular diphtheria, tetanus toxoids, whole-cell pertussis, hepatitis B, IPV, Haemophilus influenzae type b (DTwP-HepB-IPV/Hib) vaccination to toddlers 20 . These results have paved the way for further clinical investigations of IPV-Al in phase 3 trials.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity and safety of three aluminium hydroxide adjuvanted vaccines with reduced doses of inactivated polio vaccine (IPV-Al) compared with standard IPV in young infants in the Dominican Republic: a phase 2, non-inferiority, observer-blinded, randomised, and controlled dose investigation trial

Rivera¹,

Pedersen

Peña³

et al. 2017

The Lancet Infectious Diseases

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SummaryBackgroundCost and supply constraints are key challenges in the use of inactivated polio vaccine (IPV). Dose reduction through adsorption to aluminium hydroxide (Al) is a promising option, and establishing its effectiveness in the target population is a crucial milestone in developing IPV-Al. The aim of this clinical trial was to show the non-inferiority of three IPV-Al vaccines to standard IPV.MethodsIn this phase 2, non-inferiority, observer-blinded, randomised, controlled, single-centre trial in the Dominican Republic, healthy infants aged 6 weeks, not previously polio vaccinated, were allocated after computer-generated randomisation by block-size of four, to receive one of four IPV formulations (three-times reduced dose [1/3 IPV-Al], five-times reduced dose [1/5 IPV-Al], ten-times reduced dose [1/10 IPV-Al], or IPV) intramuscularly in the thigh at 6, 10, and 14 weeks of age. The primary outcome was seroconversion for poliovirus types 1, 2, and 3 with titres more than or equal to four-fold higher than the estimated maternal antibody titre and more than or equal to 8 after three vaccinations. Non-inferiority was concluded if the lower two-sided 90% CI of the seroconversion rate difference between IPV-Al and IPV was greater than −10%. The safety analyses were based on the safety analysis set (randomly assigned participants who received at least one trial vaccination) and the immunogenicity analyses were based on the per-protocol population. This study is registered with ClinicalTrials.gov registration, number NCT02347423.FindingsBetween Feb 2, 2015, and Sept 26, 2015, we recruited 824 infants. The per-protocol population included 820 infants; 205 were randomly assigned to receive 1/3 IPV-Al, 205 to receive 1/5 IPV-Al, 204 to receive 1/10 IPV-Al, and 206 to receive IPV. The proportion of individuals meeting the primary endpoint of seroconversion for poliovirus types 1, 2, and 3 was already high for the three IPV-Al vaccines after two vaccinations, but was higher after three vaccinations (ie, after completion of the expanded programme of immunisation schedule): 1/3 IPV-Al 98·5% (n=202, type 1), 97·6% (n=200; type 2), and 99·5% (n=204, type 3); 1/5 IPV-Al: 99·5% (n=204, type 1), 96·1% (n=197, type 2), and 98·5% (n=202, type 3); and 1/10 IPV-Al: 98·5% (n=201, type 1), 94·6% (n=193, type 2), and 99·5% (n=203, type 3). All three IPV-Al were non-inferior to IPV, with absolute differences in percentage seroconversion for each poliovirus type being greater than −10% (1/3 IPV-Al type 1, −1·46 [–3·60 to 0·10], type 2, −0·98 [–3·62 to 1·49], and type 3, −0·49 [–2·16 to 0·86]; 1/5 IPV-Al type 1, −0·49 [–2·16 to 0·86], type 2, −2·45 [–5·47 to 0·27], and type 3, −1·46 [–3·60 to 0·10]; and 1/10 IPV-Al type 1, −1·47 [–3·62 to 0·10], type 2, −3·94 [–7·28 to −0·97], and type 3, −0·49 [–2·17 to 0·86]). Three serious adverse events occurred that were unrelated to the vaccine.InterpretationThe lowest dose (1/10 IPV-Al) of the vaccine performed well both after two and three doses. Based on these results, this new vaccine is und...

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Section: Discussionmentioning

confidence: 99%

Immunogenicity and safety of three aluminium hydroxide adjuvanted vaccines with reduced doses of inactivated polio vaccine (IPV-Al) compared with standard IPV in young infants in the Dominican Republic: a phase 2, non-inferiority, observer-blinded, randomised, and controlled dose investigation trial

Rivera¹,

Pedersen

Peña³

et al. 2017

The Lancet Infectious Diseases

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“…The National Institute of Public Health and Environmental Protection (RIVM) in the Netherlands developed a combined DTPw and IPV vaccine in 1962 that used 2-phenoxyethanol rather than thiomersal as preservative. A hexavalent whole-cell pertussis vaccine combination containing IPV was recently shown to be immunogenic in infants (Quiambao et al 2012). A combined DTPw, IPV, and H. influenzae type b vaccine that also used 2-phenoxyethanol as preservative was produced by Sanofi Pasteur (Pentacoq) (iDrugInfo.…”

Section: Whole-cell Inactivatedvaccinesmentioning

confidence: 99%

Vaccine Analysis: Strategies, Principles, and Control

Nunnally¹,

Turula²,

Sitrin³

2015

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“…In November 2012, the WHO Strategic Advisory Group of Experts on Immunization therefore recommended that all countries should introduce at least one dose of IPV in their routine immunization programmes to mitigate the risks and consequences associated with the eventual withdrawal of serotype 2 OPV [133]. In the longer term, combination vaccines containing IPV, whole cell pertussis and other antigens are likely to be a sustainable option and are currently under development by a number of manufacturers [134]. …”

Section: Challenges To the Eradication Of All Poliovirusesmentioning

confidence: 99%

The final stages of the global eradication of poliomyelitis

Grassly

2013

Phil. Trans. R. Soc. B

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The global incidence of poliomyelitis has dropped by more than 99 per cent since the governments of the world committed to eradication in 1988. One of the three serotypes of wild poliovirus has been eradicated and the remaining two serotypes are limited to just a small number of endemic regions. However, the Global Polio Eradication Initiative (GPEI) has faced a number of challenges in eradicating the last 1 per cent of wild-virus transmission. The polio endgame has also been complicated by the recognition that vaccination with the oral poliovirus vaccine (OPV) must eventually cease because of the risk of outbreaks of vaccine-derived polioviruses. I describe the major challenges to wild poliovirus eradication, focusing on the poor immunogenicity of OPV in lower-income countries, the inherent limitations to the sensitivity and specificity of surveillance, the international spread of poliovirus and resulting outbreaks, and the potential significance of waning intestinal immunity induced by OPV. I then focus on the challenges to eradicating all polioviruses, the problem of vaccine-derived polioviruses and the risk of wild-type or vaccine-derived poliovirus re-emergence after the cessation of oral vaccination. I document the role of research in the GPEI's response to these challenges and ultimately the feasibility of achieving a world without poliomyelitis.

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Cited by 12 publications

References 8 publications

Immunogenicity and safety of three aluminium hydroxide adjuvanted vaccines with reduced doses of inactivated polio vaccine (IPV-Al) compared with standard IPV in young infants in the Dominican Republic: a phase 2, non-inferiority, observer-blinded, randomised, and controlled dose investigation trial

Immunogenicity and safety of three aluminium hydroxide adjuvanted vaccines with reduced doses of inactivated polio vaccine (IPV-Al) compared with standard IPV in young infants in the Dominican Republic: a phase 2, non-inferiority, observer-blinded, randomised, and controlled dose investigation trial

Vaccine Analysis: Strategies, Principles, and Control

The final stages of the global eradication of poliomyelitis

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