PregnancyVARI-IMMNCT02775422
Comparison of Serological Test s for the Virus Chicken Pox Virus (VZV) and Correlation With the Patient's Memory of the Infection or Vaccination
A study testing Serological Test s for the Virus Chicken Pox Virus in people with Pregnancy, run by Hopital Foch at 1 site in France.
Trial summary
Comparison of the sensibility and specificity of 3 different serological tests and evaluation of chicken pox immunity in pregnant women. Secondary goals : Correlation memory / Immunity; Prevalence of VZV immunity in pregnant women; Evaluation of cellular and humoral immunity in cases with discrepancy between tests or… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Serological Test s for the Virus Chicken Pox Virus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2015to 26 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women aged over 18
- Affiliated to a social protection scheme or women benefiting from such a regime
- Women who gived a writing consent
Who cannot join
- Women with a maternal disease: autoimmune disease (systemic lupus erythematosus, antiphospholipid syndrome, insulin dependent diabetes, autoimmune thyroiditis ..), it takes an immunosuppressive treatment or not.
- HIV-positive women
- Garfted women whatever organ
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Serological Tests for the Varicella-zoster Virus and Correlation With the Memory of the Infection or Vaccination
Comparison of the sensibility and specificity of 3 different serological tests and evaluation of chicken pox immunity in pregnant women.
Secondary goals :
- Correlation memory / Immunity;
- Prevalence of VZV immunity in pregnant women;
- Evaluation of cellular and humoral immunity in cases with discrepancy between tests or between test and memory;
- Evaluation of acceptability of vaccination in the post partum period in non immune patients.
Methods Not randomized prospective study,
Number of patients : 400 Duration : 36 months Inclusion criteria : pregnant women >18years old, agree to participate (written consent) Exclusion criteria: auto immune disease, HIV +, grafted patients
- Conditions
- Pregnancy
- Being tested
- Serological Test s for the Virus Chicken Pox Virus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological Test s for the Virus Chicken Pox VirusBiological
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Experimental | Pregnant women Receives: Biological: Serological Test s for the Virus Chicken Pox Virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate sensitivity and specificity in negative and dubious zone for the assessment of the serology of anti VZV immunity
Measured: 35 weeks
Secondary outcomes (2)
frequency of immunity detecting depending on whether the patient remember having varicella, have been in contact with next of kin with varicella or been vaccinated against varicella or not
Measured: up to 35 weeks
Percentage of women accepting the vaccination in case of negative history
Measured: day during the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start30 Mar 2015
- Primary completion26 Jul 2020
- Study completion26 Jul 2020
Why it stopped: Low inclusion rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Picone, MD, Principal investigator, Service Gynécologie Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775422
- Sponsor's protocol ID
- 2014/08
- Other IDs
- 2014-A00707-40
- Acronym
- VARI-IMM
- Status last verified
- Aug 2019
- First submitted
- 12 May 2016
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
LAFORET EG, LYNCH CL Jr. Multiple congenital defects following maternal varicella; report of a case. N Engl J Med. 1947 Apr 10;236(15):534-7. doi: 10.1056/NEJM194704102361504. No abstract available.
PubMed 20293114Alkalay AL, Pomerance JJ, Rimoin DL. Fetal varicella syndrome. J Pediatr. 1987 Sep;111(3):320-3. doi: 10.1016/s0022-3476(87)80447-x. No abstract available.
PubMed 3625399SAUERBREI A. Fetales varizellen syndrom. Monatsschr kinderheiledkd 2003;151:209-213.
Miller E, Cradock-Watson JE, Ridehalgh MK. Outcome in newborn babies given anti-varicella-zoster immunoglobulin after perinatal maternal infection with varicella-zoster virus. Lancet. 1989 Aug 12;2(8659):371-3. doi: 10.1016/s0140-6736(89)90547-3.
PubMed 2569560ENDERS G. Varicella and herpes zoster in pregnancy and the newborn. . Varicella-zoster virus and clinical management. Arvin AM and Gershon AA, eds; UK: Cambridge University Press 2000:317-347.
MIRLESSE V. Varicelle et grossesse. Les virus transmissibles de la mère à l'enfant. Denis F. Ed John Libey Eurotext, In Montrouge 1999:252-269.
Khoshnood B, Debruyne M, Lancon F, Emery C, Fagnani F, Durand I, Floret D. Seroprevalence of varicella in the French population. Pediatr Infect Dis J. 2006 Jan;25(1):41-4. doi: 10.1097/01.inf.0000195636.43584.bb.
PubMed 16395101Wu MF, Yang YW, Lin WY, Chang CY, Soon MS, Liu CE. Varicella zoster virus infection among healthcare workers in Taiwan: seroprevalence and predictive value of history of varicella infection. J Hosp Infect. 2012 Feb;80(2):162-7. doi: 10.1016/j.jhin.2011.11.011. Epub 2011 Dec 19.
PubMed 22188630Vandersmissen G, Moens G, Vranckx R, de Schryver A, Jacques P. Occupational risk of infection by varicella zoster virus in Belgian healthcare workers: a seroprevalence study. Occup Environ Med. 2000 Sep;57(9):621-6. doi: 10.1136/oem.57.9.621.
PubMed 10935943Alp E, Cevahir F, Gokahmetoglu S, Demiraslan H, Doganay M. Prevaccination screening of health-care workers for immunity to measles, rubella, mumps, and varicella in a developing country: What do we save? J Infect Public Health. 2012 Apr;5(2):127-32. doi: 10.1016/j.jiph.2011.11.003. Epub 2012 Jan 18.
PubMed 22541258Almuneef M, Memish ZA, Abbas ME, Balkhy HH. Screening healthcare workers for varicella-zoster virus: can we trust the history? Infect Control Hosp Epidemiol. 2004 Jul;25(7):595-8. doi: 10.1086/502445.
PubMed 15301033Saadatian-Elahi M, Mekki Y, Del Signore C, Lina B, Derrough T, Caulin E, Thierry J, Vanhems P. Seroprevalence of varicella antibodies among pregnant women in Lyon-France. Eur J Epidemiol. 2007;22(6):405-9. doi: 10.1007/s10654-007-9136-z. Epub 2007 May 30.
PubMed 17534728Reignier F, Romano L, Thiry N, Beutels P, Van Damme P, Fau C, Gaspard C, Mamoux V, Zanetti A, Floret D. [Varicella-zoster virus seroprevalence in nursery and day-care workers in Lyon (France)]. Med Mal Infect. 2005 Apr;35(4):192-6. doi: 10.1016/j.medmal.2005.01.007. French.
PubMed 15914287Dashraath P, Ong ES, Lee VJ. Seroepidemiology of varicella and the reliability of a self-reported history of varicella infection in Singapore military recruits. Ann Acad Med Singap. 2007 Aug;36(8):636-41.
PubMed 17767333Fung LW, Lao TT, Suen SS, Chan OK, Lau TK, Ngai KL, Chan PK, Leung TY. Seroprevalence of varicella zoster virus among pregnant women in Hong Kong: comparison with self-reported history. Vaccine. 2011 Oct 26;29(46):8186-8. doi: 10.1016/j.vaccine.2011.08.090. Epub 2011 Sep 10.
PubMed 21911021
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serological Tests for the Varicella-zoster Virus and Correlation With the Memory of the Infection or Vaccination
- ClinicalTrials.gov ID
- NCT02775422
- Acronym / sponsor ID
- VARI-IMM / 2014/08
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low inclusion rate.
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 30 Mar 2015 (actual)
- Primary completion
- 26 Jul 2020 (actual)
- Study completion
- 26 Jul 2020 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of the sensibility and specificity of 3 different serological tests and evaluation of chicken pox immunity in pregnant women.
Secondary goals :
- Correlation memory / Immunity;
- Prevalence of VZV immunity in pregnant women;
- Evaluation of cellular and humoral immunity in cases with discrepancy between tests or between test and memory;
- Evaluation of acceptability of vaccination in the post partum period in non immune patients.
Methods Not randomized prospective study,
Number of patients : 400 Duration : 36 months Inclusion criteria : pregnant women >18years old, agree to participate (written consent) Exclusion criteria: auto immune disease, HIV +, grafted patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | Experimental | Biological: Serological Test s for the Virus Chicken Pox VirusPregnant women |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women aged over 18
- Affiliated to a social protection scheme or women benefiting from such a regime
- Women who gived a writing consent
Key exclusion criteria (3 listed)
- Women with a maternal disease: autoimmune disease (systemic lupus erythematosus, antiphospholipid syndrome, insulin dependent diabetes, autoimmune thyroiditis ..), it takes an immunosuppressive treatment or not.
- HIV-positive women
- Garfted women whatever organ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serological Test s for the Virus Chicken Pox Virus | Biological | Pregnant women |
Primary outcome
Rate sensitivity and specificity in negative and dubious zone for the assessment of the serology of anti VZV immunity
Time frame: 35 weeks
2 secondary outcomes
frequency of immunity detecting depending on whether the patient remember having varicella, have been in contact with next of kin with varicella or been vaccinated against varicella or not
Time frame: up to 35 weeks
Percentage of women accepting the vaccination in case of negative history
Time frame: day during the first visit
Results and safety
The study was stopped early (reason given: Low inclusion rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Background: PubMed 20293114LAFORET EG, LYNCH CL Jr. Multiple congenital defects following maternal varicella; report of a case. N Engl J Med. 1947 Apr 10;236(15):534-7. doi: 10.1056/NEJM194704102361504. No abstract available.
- Background: PubMed 3625399Alkalay AL, Pomerance JJ, Rimoin DL. Fetal varicella syndrome. J Pediatr. 1987 Sep;111(3):320-3. doi: 10.1016/s0022-3476(87)80447-x. No abstract available.
- BackgroundSAUERBREI A. Fetales varizellen syndrom. Monatsschr kinderheiledkd 2003;151:209-213.
- Background: PubMed 2569560Miller E, Cradock-Watson JE, Ridehalgh MK. Outcome in newborn babies given anti-varicella-zoster immunoglobulin after perinatal maternal infection with varicella-zoster virus. Lancet. 1989 Aug 12;2(8659):371-3. doi: 10.1016/s0140-6736(89)90547-3.
- BackgroundENDERS G. Varicella and herpes zoster in pregnancy and the newborn. . Varicella-zoster virus and clinical management. Arvin AM and Gershon AA, eds; UK: Cambridge University Press 2000:317-347.
- BackgroundMIRLESSE V. Varicelle et grossesse. Les virus transmissibles de la mère à l'enfant. Denis F. Ed John Libey Eurotext, In Montrouge 1999:252-269.
- Background: PubMed 16395101Khoshnood B, Debruyne M, Lancon F, Emery C, Fagnani F, Durand I, Floret D. Seroprevalence of varicella in the French population. Pediatr Infect Dis J. 2006 Jan;25(1):41-4. doi: 10.1097/01.inf.0000195636.43584.bb.
- Background: PubMed 22188630Wu MF, Yang YW, Lin WY, Chang CY, Soon MS, Liu CE. Varicella zoster virus infection among healthcare workers in Taiwan: seroprevalence and predictive value of history of varicella infection. J Hosp Infect. 2012 Feb;80(2):162-7. doi: 10.1016/j.jhin.2011.11.011. Epub 2011 Dec 19.
- Background: PubMed 10935943Vandersmissen G, Moens G, Vranckx R, de Schryver A, Jacques P. Occupational risk of infection by varicella zoster virus in Belgian healthcare workers: a seroprevalence study. Occup Environ Med. 2000 Sep;57(9):621-6. doi: 10.1136/oem.57.9.621.
- Background: PubMed 22541258Alp E, Cevahir F, Gokahmetoglu S, Demiraslan H, Doganay M. Prevaccination screening of health-care workers for immunity to measles, rubella, mumps, and varicella in a developing country: What do we save? J Infect Public Health. 2012 Apr;5(2):127-32. doi: 10.1016/j.jiph.2011.11.003. Epub 2012 Jan 18.
- Background: PubMed 15301033Almuneef M, Memish ZA, Abbas ME, Balkhy HH. Screening healthcare workers for varicella-zoster virus: can we trust the history? Infect Control Hosp Epidemiol. 2004 Jul;25(7):595-8. doi: 10.1086/502445.
- Background: PubMed 17534728Saadatian-Elahi M, Mekki Y, Del Signore C, Lina B, Derrough T, Caulin E, Thierry J, Vanhems P. Seroprevalence of varicella antibodies among pregnant women in Lyon-France. Eur J Epidemiol. 2007;22(6):405-9. doi: 10.1007/s10654-007-9136-z. Epub 2007 May 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Picone, MD principal investigator
Service Gynécologie Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serological Test s for the Virus Chicken Pox Virus in people with Pregnancy, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low inclusion rate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate sensitivity and specificity in negative and dubious zone for the assessment of the serology of anti VZV immunity (time frame: 35 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02775422, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.