ATTENUVAX SUMMARY
ATTENUVAX (Measles Virus Vaccine Live) is a live virus vaccine for vaccination against measles (rubeola).
ATTENUVAX is indicated for vaccination against measles in persons 12 months of age or older.
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NEWS HIGHLIGHTS
Published Studies Related to Attenuvax (Measles Vaccine)
Antibiotics for preventing complications in children with measles. [2013]
CONCLUSIONS: The studies reviewed were of poor quality and used older
Immunogenicity and safety of combined measles-mumps-rubella-varicella vaccine
using new measles and rubella working seeds in healthy children in Taiwan and
Singapore: a phase II, randomized, double-blind trial. [2013]
seed virus stock, in Taiwanese and Singaporean children (NCT00892775)... CONCLUSION: The immune responses elicited by the MMRV(new WS) vaccine were
Increasing the time of exposure to aerosol measles vaccine elicits an immune response equivalent to that seen in 9-month-old Mexican children given the same dose subcutaneously. [2011.08.01]
BACKGROUND: A 30-second aerosol measles vaccination successfully primes children 12 months of age and older but is poorly immunogenic when given to 9-month-old children. We examined the immune responses when increasing the duration to aerosol exposure in 9-month-olds... CONCLUSIONS: Increasing exposure time to aerosol measles vaccine elicits immune responses that are comparable to those seen when an equivalent dose is administered by the subcutaneous route in 9-month-old infants.
Safety and immunogenicity of early measles vaccination in children born to HIV-infected mothers in the United States: results of Pediatric AIDS Clinical Trials Group (PACTG) protocol 225. [2011.07]
BACKGROUND.: ACTG (Pediatric AIDS Clinical Trials Group) 225, a multicenter, randomized, open-label trial in the United States evaluated reactogenicity and immunogenicity of 2 vaccination regimens: monovalent measles vaccine (Attenuvax) at 6 months of age and measles, mumps, and rubella, live attenuated (MMRII) vaccine at 12 months of age (2D), or only MMRII at 12 months of age (1D) in human immunodeficiency virus-infected (HIV-infected) (POS) and uninfected (NEG) children in the pre-highly active antiretroviral therapy (pre-HAART) period... CONCLUSIONS: Among HIV-infected children pre-HAART, Attenuvax at 6 months was well tolerated and immunogenic. These data support the current World Health Organization (WHO) recommendation to administer a first dose of measles vaccine at 6 months of age to HIV-infected children. (c) The Author 2011. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved.
Persistence of vaccine-induced measles antibody beyond age 12 months: a comparison of response to one and two doses of Edmonston-Zagreb measles vaccine among HIV-infected and uninfected children in Malawi. [2011.07]
BACKGROUND: Previously, we demonstrated that measles antibody prevalence was lower at age 12 months among children infected with human immunodeficiency virus (HIV) than uninfected children following measles vaccination (MV) at ages 6 and 9 months. Among HIV-uninfected children, measles antibody prevalence was lower among 1- than 2-dose MV recipients...
Clinical Trials Related to Attenuvax (Measles Vaccine)
Trial of Additional Measles Vaccine to Reduce Child Mortality [Recruiting]
Background: All observational studies and a few randomised controlled trials (RCT) suggest
that early measles vaccine (MV), in particular an early two-dose strategy, has a much better
effect on overall mortality than later MV. These results suggest that MV has a non-measles
related beneficial effect on child survival.
Objective: To evaluate in a two-site RCT the effect on child survival and other health
indicators of a two-dose measles vaccination schedule by providing an additional dose of
Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard
measles vaccine at 9 months of age. The trials are planned in Guinea-Bissau and Burkina
Faso. The investigators will test a 40-43% reduction of mortality at each site separately
and a 32% reduction overall. Based on the results from the RCT, the investigators will
assess the cost-effectiveness of the intervention.
Design, Guinea-Bissau: Newborns are followed through the Health and Demographic Surveillance
System (HDSS) of the Bandim Health Project. Information on routine and campaign vaccinations
will be collected regularly through home visits and health centre registers. Four weeks
after having received the third dose of pentavalent vaccine (Penta3), the children will be
eligible for enrollment in the trial if they are not severely ill. Eligible children will be
invited to take part in the trial. Provided parental informed consent is given, the children
will be randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will
be based on consumption of services and average cost per unit. The incremental cost
effectiveness ratio will be calculated.
Sample size, follow-up and analyses: To detect a 40% reduction in overall mortality at each
site the investigators intend to enroll at least 3,750 children in Guinea-Bissau. The
children will be followed for survival and hospitalisations to 3 years of age or to the end
of the study after three years. The investigators will analyse the effects by site and
combined; by sex and season; possible interactions with other interventions like campaigns
with drugs, vaccines or micronutrients will be explored.
Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of
maternal antibody levels on subsequent antibody responses to MV. The children will be
followed to 24 months of age and samples collected at 4, 9 and 24 months of age.
Trial of Additional Measles Vaccine to Reduce Child Mortality. Burkina Faso. [Recruiting]
Background: All observational studies and a few randomised controlled trials (RCT) suggest
that early measles vaccine (MV), in particular an early two-dose strategy, has a much better
effect on overall mortality than later MV. These results suggest that MV has a non-measles
related beneficial effect on child survival.
Objective: To evaluate in a multi-center RCT the effect on child survival and other health
indicators of a two-dose measles vaccination schedule by providing an additional dose of
Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard
measles vaccine at 9 months of age. Three trials are planned in Guinea-Bissau, Ghana and
Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site
separately and a 32% reduction overall. Based on the results from the RCT, the investigators
will assess the cost-effectiveness of the intervention.
Design, Burkina Faso: Newborns are followed through the Health and Demographic Surveillance
System (HDSS) of the Centre de Recherche en Sante de Nouna. Information on routine and
campaign vaccinations will be collected regularly through home visits and health centre
registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3),
the children will be eligible for enrollment in the trial if they are not severely ill.
Eligible children will be invited to take part in the trial. Provided parental informed
consent is given, the children will be randomised to MV at 4 and 9 months of age or only at
9 months. Cost estimates will be based on consumption of services and average cost per unit.
The incremental cost effectiveness ratio will be calculated.
Sample size, follow-up and analyses: To detect a 43% reduction in overall mortality at each
site the investigators intend to enroll at least 4050 children in Burkina Faso. The children
will be followed for survival and hospitalisations to 3 years of age or to the end of the
study after three years. The investigators will analyse the effects by site and combined; by
sex and season; possible interactions with other interventions like campaigns with drugs,
vaccines or micronutrients will be explored.
Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of
maternal antibody levels on subsequent antibody responses to MV. The children will be
followed to 24 months of age and samples collected at 4, 9 and 24 months of age.
Additional Measles Vaccine at 4 Months of Age [Recruiting]
Overall objective: To conduct a randomised controlled trial (RCT) to examine whether an
early two-dose measles vaccination (MV) strategy at 4 and 9 months will reduce child
mortality compared with the WHO strategy of one dose of MV at 9 months.
Specific hypotheses Hypothesis I) Two doses of MV at 4 and 9 months compared with the
standard dose of MV at 9 months will reduce mortality by 30% between 4 months and 5 years of
age1. As in a previous trial it is expected that the beneficial effect is strongest for
girls.
Hypothesis II) Children receiving MV at 4 months in the presence of maternal measles
antibodies (MatAb) will have 35% lower mortality between 4 months and 5 years of age than
children receiving MV at 4 months with no detectable MatAb.
Implications: These hypotheses are based on a previous RCT showing strong beneficial effects
of providing an early measles vaccine, in particular among children with MatAb.
A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices [Completed]
This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be
given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV
by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Subjects will
be followed for 180 days for safety.
Measles Vaccine in Patients With Measles Virus-Positive, Advanced Non-Small Cell Lung Cancer [Not yet recruiting]
The objectives of the study are to assess the efficacy and safety of live, attenuated
measles vaccine as consolidation therapy in patients with measles-positive, non-small cell
lung cancer with locally-advanced (stage 3B with pleural effusion) or metastatic (stage 4)
tumors in remission.
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Page last updated: 2014-11-30
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