Immunogenicity, safety and tolerability of varying doses and regimens of inactivated hepatitis A virus vaccine in Navajo children

Newcomer, Wendy; Rivin, Beth; Reid, Raymond; Moulton, Lawrence H.; Wolff, Mark; Croll, Janné; Johnson, C.L.; Brown, Leora; Nalin, David R.; Santosham, Mathuram

doi:10.1097/00006454-199407000-00011

Cited by 19 publications

(14 citation statements)

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“…Confounding between the dose and the ages of the recipients (pediatric or adult), the number of injections received (two or three) or the study site does not seem to explain this pattern. Further, higher doses were not always associated with higher antibody responses (GMTs) to the original vaccination series in studies reported by Newcomer et al [1994] and Block et al r19931. While this observation may be the result of over-analyzing a limited amount of data, the relationship between the dose of vaccine received and the duration of detectable antibody warrants further study.…”

Section: Discussionmentioning

confidence: 96%

“…Immune memory is the basis for lifelong protection from disease in people immune due to previous infection [Villarejos et al, 19821. The presence of immune memory after a single injection of VAQTAB has been demonstrated by a sharp rise in antibody levels after a booster injection of VAQTAB [Block et al, 1993;Kuter et al, 1991;Midthun et al, 1991Midthun et al, ,1992Newcomer et al, 1994;Shouval et al, 1993;Nalin, 19951. The expected duration of detectable vaccine-induced antibody to HAV has been debated. Estimated duration of antibody persistence from a different hepatitis A vaccine has been discussed in several articles [Tilzey et al, 1992;Davidson et al, 1992;Wiedermann et al, 1992;Van Damme et al, 19941.…”

Section: Introductionmentioning

confidence: 99%

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Duration of protection from clinical hepatitis A disease after vaccination with VAQTA®

Wiens¹,

Bohidar²,

Pigeon³

et al. 1996

J. Med. Virol.

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Recent papers examining the expected persistence of anti-hepatitis A virus antibody following vaccination with inactivated hepatitis A vaccine have estimated that geometric mean antibody levels will remain above cut-off levels for 10-30 years. However, the methodology used in these papers did not take into account any estimates of variability between subjects. In this paper data from the persistence of antibody after the administration of another vaccine, VAQTA (hepatitis A vaccine, inactivated; MSD), were used to develop further models of antibody decay. Using individual subject estimates instead of group means allowed the estimation of time to negativity for various percentiles of the population (including the median), and the construction of confidence intervals on estimates of time to negativity. Data from studies of subjects who seroreverted to negativity, and subsequently received a booster dose, were also considered to show that subjects who lose detectable antibody are likely to remain protected from hepatitis A disease by persistent immune memory and rapid anamnestic response soon after exposure to hepatitis A virus. The estimates of duration of protection suggest that VAQTA will provide protection for many years, first through presence of antibody and further through an anamnestic response based on persistent immune memory.

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Section: Discussionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

Duration of protection from clinical hepatitis A disease after vaccination with VAQTA®

Wiens¹,

Bohidar²,

Pigeon³

et al. 1996

J. Med. Virol.

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“…The study was approved by the White Mountain Apache Tribe, the Indian Health Service Institutional Review Board, and the Committee on Human Research at the Johns Hopkins University School of Hygiene and Public Health. After written informed consent was obtained from the mothers, a birth cohort of 50 newborn infants was enrolled between 1 June 1983 and 23 April 1986 in a study of bacterial polysaccharide immunoglobulin (Ig) to prevent infections due to Haemophilus influenzae (36). During this period, 628 infants were born in the reservation.…”

Section: Methodsmentioning

confidence: 99%

Transient and PersistentHelicobacter pyloriColonization in Native American Children

et al. 2003

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Helicobacter pylori is chiefly acquired in childhood, but the exact timing of acquisition is not well understood. The main goal of this study was to assess H. pylori acquisition in a pediatric population. We studied two cohorts of Native American children: a birth cohort of 50 children and 58 older children (mean age, 53 months). We measured serum immunoglobulin G (IgG), IgM, and IgA antibodies to H. pylori whole-cell antigen and IgG antibodies to CagA. Among 44 birth cohort children monitored for more than 12 months, 24 (54.5%) had seroconversions, 7 (15.9%) were transient, and 17 (38.6%) were persistent. Among the older children, 49 (84.5%) of the 58 children were monitored for 1 year; 34 (69.4%) had H. pylori antibodies at study entry. During the next year, 7 (20.6%) children seroreverted, and of 15 initially negative children, 5 (33.3%) seroconverted. In both groups, evaluation of CagA antibodies increased the sensitivity of H. pylori detection. Serum pepsinogen I (PGI) levels in H. pylori-negative children rose significantly until age 6 months and remained constant for the next 19 months. At the time of H. pylori seroconversion, PGI peaked to levels significantly higher than in the never-seroconverted (P ‫؍‬ 0.02) and the pre-seroconverted (P ‫؍‬ 0.03) children, but then declined to levels paralleling those of H. pylori-negative children. Thus, H. pylori acquisition, accompanied by a transient PGI increase, was frequent in this population, especially in the second and third years of life, but often was brief.Gastric colonization by Helicobacter pylori is highly prevalent throughout the world (3,15,41), and the organism is predominantly acquired during childhood (19,34). In developing countries, more than 80% of adults are colonized with H. pylori, and more than 50% of children become colonized before the age of 10 years compared to 30% of the adults and 10% of children in developed countries like the United States (15-17, 50, 66). With socioeconomic development, the prevalence of H. pylori has declined (26,48,50). H. pylori colonization generally persists throughout life, except in persons treated with antibiotics or those who develop atrophic gastritis, usually late in life (18,70). Although most adults have no clinical consequences of H. pylori colonization, it is a risk factor for peptic ulcer disease (7, 15, 37) and noncardia gastric adenocarcinoma (22,38). While colonization of adults with H. pylori almost always persists (26,42,48), there has been evidence for both transient and persistent colonization in children (19, 65) and in experimentally challenged nonhuman primates (12). The relative frequency of transient H. pylori acquisition among children in developing countries has been only partially characterized (29,58,65), and there is little information about gastric physiology in children in relation to H. pylori acquisition (58). An important question is whether pepsinogen production, reflecting gastric acidity (71), is affected by the H. pylori status of the child.The Native American Apache people...

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“…Both vaccines are well tolerated, however, with the frequency of adverse events similar to that with hepatitis B vaccine. 20,79,[85][86][87][88] Local reactions are common but generally mild. Soreness at the site of intramuscular injection occurs in 21 to 56 percent of Havrix recipients, and fever in up to 4 percent.…”

Section: Adverse Eventsmentioning

confidence: 99%

Vaccines to Prevent Viral Hepatitis

1997

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Immunogenicity, safety and tolerability of varying doses and regimens of inactivated hepatitis A virus vaccine in Navajo children

Cited by 19 publications

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Duration of protection from clinical hepatitis A disease after vaccination with VAQTA®

Duration of protection from clinical hepatitis A disease after vaccination with VAQTA®

Transient and PersistentHelicobacter pyloriColonization in Native American Children

Vaccines to Prevent Viral Hepatitis

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