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DiarrheaPhase 1NCT01375907

Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults

A Phase 1 study testing Rotavin in people with Diarrhea and Vomit, run by National Institute of Hygiene and Epidemiology, Vietnam at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Diarrhea, Vomit, Fever
What is being tested?
Rotavin
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteVietnam
Study dates
Aug 2009to Oct 2009
Phase
Phase 1
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 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • At dose 1
  • Healthy male or female, 18 to 40 years of age,
  • Free of disease,
  • Written informed consent obtained from subjects. At dose 2
  • Received dose 1.
  • Oral informed consent obtained from subject for continuing participate the study.

Who cannot join

  • At dose 1
  • Pregnant woman or planning to be pregnant during the study period.
  • Has a chronic disease (cardiovascular, liver, kidney disease).
  • Acute disease at the time of enrolment.
  • Administering corticosteroids (> 1mg/kg/day).
  • Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks).
Show all 21Show fewer
  • Immunosuppressive or immunodeficient condition.
  • Allergic or reaction with any component of vaccine, includes anaphylactic and shock with any antibiotic.
  • Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination.
  • Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
  • Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.
  • At dose 2
  • Pregnant woman or planning to be pregnant in next 1 month.
  • Acute disease at the time of 2nd dose.
  • Administering corticosteroids (> 1mg/kg/day).
  • Received any immunosuppressive therapy within 4 week before vaccination (administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks).
  • Immunosuppressive or immunodeficient condition.
  • History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
  • Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination.
  • Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
  • Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Preventive Medicine Center

    Thanh Sơn, Phu Tho

Other trials in Vietnam

About this study

Official title: A Phase 1 Study to Evaluate Safety and Reactogenicity of a Vietnamese Rotavirus Vaccine (Rotavin-M1 at 10e6.3FFU/Dose) Among Healthy Adults in Vietnam

The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.

Read the detailed description

Rotavirus (RV) is the most important cause of acute gastroenteritis in children worldwide. In Vietnam rotavirus causes an estimated 122,000-140,000 hospitalizations and 2900-5400 deaths per year among children under 5 years of age (1). Over the past 13 years, sentinel hospital surveillance identified rotavirus in 44%-62% of children admitted for the treatment of acute diarrhea in Vietnam (2-4). Such a high burden of disease justified accelerated development of a new and locally manufactured vaccine against rotavirus in Vietnam. It is estimated that if a vaccine was introduced in the current childhood immunization schedule, it could reduce severe rotavirus disease by about 60% or more given current vaccine efficacies and coverage (5).

The Government of Vietnam has pursued a policy to encourage local vaccine production so the country could be self-reliant with affordable vaccines for its population (6). Over the past decades, several locally produced vaccines for poliomyelitis, cholera, Japanese encephalitis, and Diphtheria-Pertussis-Tetanus have contributed to the reduction in the prevalence of these diseases and to the eradication of polio over the past decade. While two commercial rotavirus vaccines, RotarixTM (GSK, Belgium) and RotaTeq® (Merck), have both been tested in Vietnam, neither is currently available at an affordable cost for the national program. Therefore, the candidate vaccine, Rotavin-M1, was developed in order to fill this need for a more affordable vaccine for Vietnamese children (6). This vaccine is similar to RotarixTM, and was developed by selecting a common G1P[8] strain and attenuating it through serial

Being tested
Rotavin
Keywords
blood cell counts, BUN, ALT, AST, diarrhea, fever, vomit, nausea, loss of appetite, irritability
Medical subject headings
Diarrhea, Vomiting, Fever, Nausea, Anorexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RotavinDrug

    Also called Rotavin-M1

    Rotavin-M1, 10e6.3FFU/dose, 2 doses, 1-month between doses

Study groups in NCT01375907
Study groupRoleWhat they receive
RotavinExperimentalRotavin-M1 vaccine, 10e6.3FFU/dose, 2 doses, 1 month between doses
Receives: Drug: Rotavin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of Rotavin-M1 vaccine in healthy adult volunteers

    To evaluate the safety of 2 doses Rotavin-M1 vaccine (10e6.3FFU/dose, 1-month interval between doses) in healthy adult volunteers.

    Measured: 3 months

Secondary outcomes (2)

  1. Reactogenicity of Rotavin-M1 in healthy adult volunteer

    To evaluate immediate reactions (30 minutes) after administration of each dose

    Measured: 3 months

  2. Change in blood cell counts, serum transaminase and urea nitrogen concentration in adults after vaccination with Rotavin-M1

    to assess change in blood cell counts (red blood cells, white blood cells, platelets), blood urea nitrogen concentration, serum transaminase levels (AST, ALT) in adult volunteer after each dose of Rotavin-M1 10e6.3FFU/dose

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2011 (estimated)
  2. Study startAug 2009
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

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 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01375907
Sponsor's protocol ID
Rotavin01
Status last verified
Jul 2016
First submitted
19 May 2011
Last updated
4 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Anh DD, Thiem VD, Fischer TK, Canh DG, Minh TT, Tho le H, Van Man N, Luan le T, Kilgore P, von Seidlein L, Glass RI. The burden of rotavirus diarrhea in Khanh Hoa Province, Vietnam: baseline assessment for a rotavirus vaccine trial. Pediatr Infect Dis J. 2006 Jan;25(1):37-40. doi: 10.1097/01.inf.0000195635.05186.52.

    PubMed 16395100

  • Van Man N, Luan le T, Trach DD, Thanh NT, Van Tu P, Long NT, Anh DD, Fischer TK, Ivanoff B, Gentsch JR, Glass RI; Vietnam Rotavirus Surveillance Network. Epidemiological profile and burden of rotavirus diarrhea in Vietnam: 5 years of sentinel hospital surveillance, 1998-2003. J Infect Dis. 2005 Sep 1;192 Suppl 1:S127-32. doi: 10.1086/431501.

    PubMed 16088796

  • Ngo TC, Nguyen BM, Dang DA, Nguyen HT, Nguyen TT, Tran VN, Vu TT, Ogino M, Alam MM, Nakagomi T, Nakagomi O, Yamashiro T. Molecular epidemiology of rotavirus diarrhoea among children in Haiphong, Vietnam: the emergence of G3 rotavirus. Vaccine. 2009 Nov 20;27 Suppl 5:F75-80. doi: 10.1016/j.vaccine.2009.08.074.

    PubMed 19931725

  • Nguyen TA, Yagyu F, Okame M, Phan TG, Trinh QD, Yan H, Hoang KT, Cao AT, Le Hoang P, Okitsu S, Ushijima H. Diversity of viruses associated with acute gastroenteritis in children hospitalized with diarrhea in Ho Chi Minh City, Vietnam. J Med Virol. 2007 May;79(5):582-90. doi: 10.1002/jmv.20857.

    PubMed 17385670

  • Kim SY, Goldie SJ, Salomon JA. Cost-effectiveness of Rotavirus vaccination in Vietnam. BMC Public Health. 2009 Jan 21;9:29. doi: 10.1186/1471-2458-9-29.

    PubMed 19159483

  • Luan le T, Trang NV, Phuong NM, Nguyen HT, Ngo HT, Nguyen HT, Tran HB, Dang HN, Dang AD, Gentsch JR, Wang Y, Esona MD, Glass RI, Steele AD, Kilgore PE, Nguyen MV, Jiang B, Nguyen HD. Development and characterization of candidate rotavirus vaccine strains derived from children with diarrhoea in Vietnam. Vaccine. 2009 Nov 20;27 Suppl 5:F130-8. doi: 10.1016/j.vaccine.2009.08.086.

    PubMed 19931712

  • Dang DA, Nguyen VT, Vu DT, Nguyen TH, Nguyen DM, Yuhuan W, Baoming J, Nguyen DH, Le TL; Rotavin-M1 Vaccine Trial Group. A dose-escalation safety and immunogenicity study of a new live attenuated human rotavirus vaccine (Rotavin-M1) in Vietnamese children. Vaccine. 2012 Apr 27;30 Suppl 1:A114-21. doi: 10.1016/j.vaccine.2011.07.118.

    PubMed 22520120

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rotavin in people with Diarrhea and Vomit, run by National Institute of Hygiene and Epidemiology, Vietnam at 1 site in Vietnam.

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 6 inclusion and 21 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: finished, as of the sponsor's last update on 4 Jul 2016. 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 Vietnam. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety of Rotavin-M1 vaccine in healthy adult volunteers (time frame: 3 months). 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 NCT01375907, which also lists 7 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 4 Jul 2016.

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