A randomised controlled study with whole-cell or acellular pertussis vaccines in combination with regular DT-IPV vaccine and a new poliomyelitis (IPV vero) component in children 4 years of age in the Netherlands
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TitleA randomised controlled study with whole-cell or acellular pertussis vaccines in combination with regular DT-IPV vaccine and a new poliomyelitis (IPV vero) component in children 4 years of age in the Netherlands
Translated TitleEen gerandomiseerde, gecontroleerde veldproef met "whole cell" en acellulaire kinkhoest vaccins in combinatie met het reguliere DTP vaccin en een nieuwe polio (IPV vero) component bij 4-jarige kinderen in Nederland
PubliekssamenvattingIn deze veldproef is de immunogeniteit en de reactogeniteit van 3 verschillende ACVAs en WCV van het RIVM onderzocht, gecombineerd met DTP toegediend als booster bij 4-jarige kinderen. Bij deze kinderen is tevens de immuunrespons op IPVvero (geproduceerd op Vero cellen) vergeleken met het reguliere IPV-MK (geproduceerd op MK cellen). De kinderen in deze studie zijn eerder gevaccineerd met 4 doses DKTP van het RIVM op de leeftijd van 3, 4, 5 en 11 maanden. De ACVAs bevatten PT en FHA (ACV-PM), met PRN als derde component (ACV-SB) en FIM als vierde component (AVC-WL). Het was een open, gerandomiseerde, gecontroleerde studie met geblindeerde serologische bepalingen. Samenvattend geeft deze studie aan dat een toevoeging van een pertussis vaccinatie op 4-jarige leeftijd zinvol kan zijn bij een epidemische verheffing, waarbij de voorkeur uitgaat naar een combinatievaccin met een ACV- of een WCV-component vanwege de enkelvoudige toediening. Het IPVvero blijkt een zeer immunogeen vaccin te zijn en op zijn minst gelijkwaardig aan het huidige IPV-MK.<br>
In this trial we studied the immunogenicity and reactogenicity of three different ACVAs and the RIVM-WCV combined with DT-IPV, administered as a booster in children four years of age. In these children, the immune response of IPV vero (produced on Vero cells) was also evaluated, together with the regular IPV-MK (produced on MK cells). The children in this study were immunized three years earlier with four doses of the RIVM DTP-IPV at the ages of 3, 4, 5 and 11 months. The ACVAs were composed of PT and FHA (2 components of ACV-PM), PT, FHA and PRN (3 components of ACV-SB) and PT, FHA, PRN and FIM (4 components of ACV-WL). The study was an open, randomized, controlled study with a blinded serological evaluation. All the responses to the different vaccine components clearly demonstrate that the children were well primed with the DTP-IPV. In conclusion, this study demonstrates that an addition of a pertussis vaccination in four year-old children could be useful in an epidemical situation, in which a combination vaccine with an ACV- or a WCV-component requiring a single administration is preferred. IPV vero is shown to be a very immunogenic vaccine and at least similar to the regular IPV-MK.<br>
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Iron Deficiency Anemia at Time of Vaccination Predicts Decreased Vaccine Response and Iron Supplementation at Time of Vaccination Increases Humoral Vaccine Response: A Birth Cohort Study and a Randomized Trial Follow-Up Study in Kenyan Infants.Stoffel, Nicole U; Uyoga, Mary A; Mutuku, Francis M; Frost, Joe N; Mwasi, Edith; Paganini, Daniela; van der Klis, Fiona R M; Malhotra, Indu J; LaBeaud, A Desiráe; Ricci, Cristian; et al. (2020-01-01)Background: Iron deficiency may impair adaptive immunity and is common among African infants at time of vaccination. Whether iron deficiency impairs vaccine response and whether iron supplementation improves humoral vaccine response is uncertain. Methods: We performed two studies in southern coastal Kenya. In a birth cohort study, we followed infants to age 18 mo and assessed whether anemia or iron deficiency at time of vaccination predicted vaccine response to three-valent oral polio, diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine, ten-valent pneumococcal-conjugate vaccine and measles vaccine. Primary outcomes were anti-vaccine-IgG and seroconversion at age 24 wk and 18 mo. In a randomized trial cohort follow-up, children received a micronutrient powder (MNP) with 5 mg iron daily or a MNP without iron for 4 mo starting at age 7.5 mo and received measles vaccine at 9 and 18 mo; primary outcomes were anti-measles IgG, seroconversion and avidity at age 11.5 mo and 4.5 y. Findings: In the birth cohort study, 573 infants were enrolled and 303 completed the study. Controlling for sex, birthweight, anthropometric indices and maternal antibodies, hemoglobin at time of vaccination was the strongest positive predictor of: (A) anti-diphtheria and anti-pertussis-IgG at 24 wk (p = 0.0071, p = 0.0339) and 18 mo (p = 0.0182, p = 0.0360); (B) anti-pertussis filamentous hemagglutinin-IgG at 24 wk (p = 0.0423); and (C) anti-pneumococcus 19 IgG at 18 mo (p = 0.0129). Anemia and serum transferrin receptor at time of vaccination were the strongest predictors of seroconversion against diphtheria (p = 0.0484, p = 0.0439) and pneumococcus 19 at 18 mo (p = 0.0199, p = 0.0327). In the randomized trial, 155 infants were recruited, 127 and 88 were assessed at age 11.5 mo and 4.5 y. Compared to infants that did not receive iron, those who received iron at time of vaccination had higher anti-measles-IgG (p = 0.0415), seroconversion (p = 0.0531) and IgG avidity (p = 0.0425) at 11.5 mo. Interpretation: In Kenyan infants, anemia and iron deficiency at time of vaccination predict decreased response to diphtheria, pertussis and pneumococcal vaccines. Primary response to measles vaccine may be increased by iron supplementation at time of vaccination. These findings argue that correction of iron deficiency during early infancy may improve vaccine response.
Effect of the bivalent HPV vaccine on viral load of vaccine and non-vaccine HPV types in incident clearing and persistent infections in young Dutch females.van der Weele, Pascal; Breeuwsma, Martijn; Donken, Robine; van Logchem, Elske; van Marm-Wattimena, Naomi; de Melker, Hester; Meijer, Chris J L M; King, Audrey J (2019-01-01)HPV vaccination with the bivalent vaccine is efficacious against HPV16 and 18 infections and cross-protection against non-vaccine HPV types has been demonstrated. Here, we assessed (cross-) protective effects of the bivalent HPV16/18 vaccine on incident and persistent infections and viral load (VL) of fifteen HPV types in an observational cohort study monitoring HPV vaccine effects. Vaginal samples were obtained annually. Type-specific VL assays were developed for HPV6,11,31 33,35,39,45,51,52,56,58,59 and 66 and used in addition to existing HPV16 and 18 assays. Rate differences of incident clearing and persistent infections were correlated with differences in VL and vaccination status. HPV16/18 vaccination resulted in significantly lower incidence of HPV16/18 infections and significantly lower VL in breakthrough HPV16 (p<0.01) and 18 infections (p<0.01). The effects of vaccination on non-vaccine type VL were ambiguous. Incidence and/or persistence rates of HPV31, 33, 35 and 45 were reduced in the vaccinated group. However, no significant type specific VL effects were found against HPV31, 33, 45, 52 in the vaccinated group. For HPV 6, 59 and 66 no significant reductions in numbers of incident and persistent infections were found, however borderline) VL reductions following vaccination were observed for HPV6 (p = 0.01), 59 (p = 0.10) and 66 (p = 0.03), suggesting a minor effect of the vaccine on the VL level of these HPV types. Overall, vaccination resulted in infections with slightly lower VL, irrespective of HPV type. In conclusion, vaccination with the bivalent HPV16/18 vaccine results in significantly reduced numbers of HPV16 and 18 incidence rates and reduced VL in breakthrough infections. Significant reductions in incident and/or persistent HPV31, 33, 35 and 45 infections were found, but no significant effect was observed on the VL for infections with these types. For the other non-vaccine HPV types no reduction in incident and/or persistent infections were found, but overall the VL tended to be somewhat lower in vaccinated women.
Immune Responses After 2 Versus 3 Doses of HPV Vaccination up to 4½ Years After Vaccination: An Observational Study Among Dutch Routinely Vaccinated Girls.Donken, Robine; Schurink-Van't Klooster, Tessa M; Schepp, Rutger M; van der Klis, Fiona R M; Knol, Mirjam J; Meijer, Chris J L M; de Melker, Hester E (2017-02-01)In 2014 the Netherlands switched from 3 to 2 doses for routine vaccination with the prophylactic bivalent human papillomavirus (HPV) vaccine. The current study explored whether antibody responses are noninferior after 2 versus 3 doses in girls.