Persistence of Protection by Shingrix

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    140
  • sponsor
    University of Colorado, Denver
Updated on 12 March 2022
hysterectomy
vaccination
varicella
ovariectomy
chickenpox
zoster vaccine
zostavax
shingrix
Accepts healthy volunteers

Summary

The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has live virus in it, giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.

Details
Condition Herpes Zoster
Treatment Zostavax, Shingrix
Clinical Study IdentifierNCT04169009
SponsorUniversity of Colorado, Denver
Last Modified on12 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 50-85
General good health
Women of non-childbearing potential must be postmenopausal or have undergone hysterectomy or bilateral oophorectomy
ARM 1 ONLY: Documented evidence of immunization with ZVL or SRX at least 5 years previously
ARM 2 ONLY; Documented evidence of immunization with ZVL 6-12 months prior to enrollment
ARM 3 ONLY: Have never received any shingles vaccination

Exclusion Criteria

Prior history of herpes zoster (HZ)
Blood products received in the 3 months prior to study enrollment or planned for the subsequent week for Arm 1; Arm 2 requires same exclusion; Arm 3 extends the exclusion to the week after the vOka challenge, which is 6 months after completing SRX administration
Significant immune suppressive illness or therapy
Concomitant vaccine received within 2 (inactive) or 4 (live) weeks prior to the study or during the first week of the study
Women of childbearing potential
Pregnancy or breastfeeding
Participation in a concurrent clinical study in which the subject will be exposed to and investigational product during the period starting 7 days before the first dose of study vaccine through the completion of the study
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