ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12610000999033

Ethics application status

Not yet submitted

Date submitted

3/06/2010

Date registered

17/11/2010

Date last updated

17/11/2010

Type of registration

Prospectively registered

Titles & IDs

Public title

Efficacy of pneumococcal conjugate vaccine in preventing acquisition and carriage of pneumococcal vaccine serotypes in Tanzanian children with human immunodeficiency virus/ acquired immunodeficiency syndrome (HIV/AIDS)

Scientific title

Efficacy of pneumococcal conjugate vaccine in preventing acquisition and carriage of pneumococcal vaccine serotypes in Tanzanian children withhuman immunodeficiency virus/ acquired immunodeficiency syndrome (HIV/AIDS)

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1115-4400

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pneumococcal disease

HIV/AIDS

Condition category

Condition code

Public Health

Epidemiology

Infection

Studies of infection and infectious agents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Pneumococcal vaccination
1
a) containing two microgram of Pneumococcal polysaccharide
serotypes 4, 9V, 14, 18C, 19F, 23F, and four micrograms of pneumococcal polysaccharide serotype 6B. It also contains sodium chloride and water for injections.
b) two identical vaccines will be administered three months apart.
c) administered as a intramuscular injection
2
At the fourth visit to the clinic children will be given the first dose of the vaccine they have not yet received. That is children will be given four vaccinations over nine months. Firstly two doses of either control or intervention vaccine then two doses of the other vaccine in succession. There is three months between the final dose of the first type of vaccine and the first dose of the second, there is not usually a wash out in these studies. Children will be randomly allocated to receive control or treatment vaccine first. All children in the study will receive both vaccines only the order will vary.

Intervention code [1]

Prevention

Comparator / control treatment

Control vaccine Haemophilus influenzae (Hib) (Act-HIB(registered trademark)- Aventis Pasteur
Quadrace)
1
a) contains Pertussis Vaccine Combined with Diphtheria and Tetanus Toxoids combinedwith Inactivated Poliomyelitis Vaccine, the solution contains 0.6% +/- 0.1%2-phenoxyethanol as preservative
b) two identical vaccines will be administered three months apart.
c) administered as a intramuscular injection
2
At the fourth visit to the clinic children will be given the first dose of the vaccine they have not yet received. That is children will be given four vaccinations over nine months. Firstly two doses of either control or intervention vaccine then two doses of the other vaccine. Children will be randomly allocated to receive control or treatment vaccine first. All children in the study will receive both vaccines only the order will vary.

Control group

Active

Outcomes

Primary outcome [1]

Nasopharyngeal carriage of vaccine serotypes.

A nasopharyngeal swab will be obtained at the 0, 3, 6 and 9-month visit, prior to administration of the vaccine dose. Samples will be collected and processed according to the WHO working group standard methods for detecting upper respiratory carriage of S. pneumoniae and the WHO Laboratory Manual for the Diagnosis of Meningitis Caused by Neisseria meningitidis, S. pneumoniae, and H. influenzae. A paediatric calcium alginate tipped aluminium swab will be inserted through the nose into the nasopharynx, and rotated gently through 180 degrees. The swab will be placed into 1ml of Skim milk tryptone-glucose-glycerin (STGG) transport medium, made according to WHO methods.

Swabs will then be taken directly to the laboratory where they will be frozen at minus 70C until culture. Culturing will take place on 5g/ml gentamicin in sheeps blood agar.

20l of the sample will be streaked onto a plate, incubated at 35C in CO2 for two days, using a candle jar, as pneumococcus grows best under anaerobic conditions. Any samples that showing growth will then be subcultured up to four times, depending on how many colonies are present. Samples are then subcultured onto blood agar.

Facilities for serotyping are currently not available in Tanzania. Samples will be serotyped at the Kenya Medical Research Institute (KMRI) in Kilifi in Kenya by Quellung reaction. PCR serotyping at Westmead Hospital in Australia, will give us information on multiple serotype carriage.

Timepoint [1]

0, 3, 6 and 9 months

Secondary outcome [1]

Antibody response to vaccination If blood has been taken for other serologic tests then any sera left over, with the permission of the patient and parents, will be placed in EDTA tubes and frozen at -20 degrees Celsius. It will be transferred to CIDM laboratories at Westmead hospital for enzyme-linked immunosorbent assay tests to measure antibody response to the vaccine.

Timepoint [1]

0, 3, 6 and 9 months

Eligibility

Key inclusion criteria

HIV positive children aged 1-14 years old

Minimum age

1 Years

Maximum age

14 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Previous vaccination

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

HIV-positive children will be recruited when they present for routine follow-up to the clinic (usually every 1 to 3 months) and also when presenting with an illness. During each visit to The Diana Centre, they will be assessed for their need of treatment. Medical care will be provided according to national guidelines. Patients with severe disease or requiring urgent care will be transferred to the appropriate area in the hospital where this will be provided.
The following procedures will be performed:
ascertain participant eligibility,
explain the purpose of the study,
obtain written informed consent for study participation
complete the case report form
obtain and process a nasopharyngeal swab,
vaccinate the participant,
record epidemiological and treatment information from notes.
Only children with a written informed consent form, signed/thumb-printed by parents/guardians will be screened.

Participant eligibility will be ascertained through a checklist. Then the parent/guardian of the child will be requested to read the Kiswahili (local language) information sheet and informed consent form or these will be read to them. If informed consent to participate is provided, data will be collected through interview and from the patient’s medical notes. Information will be recorded in a standardised Case Report Form (CRF). The CRF is designed to investigate baseline data, such as presenting symptoms, HIV-history, socio-economic status and prophylactic and therapeutic medications. Height and weight will be measured by standard methods using calibrated scales.

As participants are recruited they will be allocated to the infant group (less than five years) or the school aged group (greater than or equal to five years). Random numbers will be generated via Excel these will then be put into brown security envelopes and stored in a file. An envelope will be taken from the file. Depending on whether this contains odd or an even number they will be assigned to receiving PCV or Hib as the first 2 doses.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

As participants are recruited they will be allocated to the infant group (less than five years) or the school aged group (greater than or equal to five years). Random numbers will be generated via specific statistical software these will then be put into brown security envelopes and stored in a file. An envelope will be taken from the file. Depending on whether this contains odd or an even number they will be assigned to receiving pneumococcal conjugate vaccine (PCV) or Hib as the first 2 doses.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/05/2011

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

216

Accrual to date

Final

Recruitment outside Australia

Country [1]

Tanzania, United Republic Of

State/province [1]

Muheza

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Prof Robert Booy

Address [1]

National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases (NCIRS)
The Children's Hospital at Westmead Cnr Hawkesbury Rd & Hainsworth St, Westmead
Post: Locked Bag 4001, Westmead NSW 2145, Australia
T: +61 2 9845 1433
F: +61 2 9845 1418

Country [1]

Australia

Primary sponsor type

Individual

Name

Prof Robert Booy

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

18/05/2010

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This is a randomised controlled trial of a pneumococcal conjugate vaccine  to examine the efficacy of this vaccine in preventing the nasopharyngeal acquisition and carriage of vaccine serotypes of pneumococcus, among Tanzanian children with HIV/AIDS. Prevention of nasopharyngeal carriage can be used as a surrogate for vaccine protective efficacy.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Prof Robert Booy

Address

National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
The Children's Hospital at Westmead Cnr Hawkesbury Rd & Hainsworth St, Westmead
Post: Locked Bag 4001, Westmead NSW 2145, Australia

T: +61 2 9845 1433
F: +61 2 9845 1418

Country

Australia

Phone

+61 2 9845 1415

Fax

[email protected]

Contact person for scientific queries

Name

Prof Robert Booy

Address

Country

Australia

Phone

+61 2 9845 1415

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Immunogenicity and Efficacy of Pneumococcal Conjugate Vaccine (Prevenar13) in Preventing Acquisition of Carriage of Pneumococcal Vaccine Serotypes in Tanzanian Children With HIV/AIDS.	2021	https://dx.doi.org/10.3389/fimmu.2021.673392

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically