AVAILABILITY OF SITE TO CONDUCT A LARGE SCALE EFFICACY TRIAL OFCANDIDATE PNEUMOCOCCAL VACCINES IN A LESS DEVELOPED COUNTRY



NIH GUIDE, Volume 23, Number 28, July 29, 1994



SOURCES SOUGHT ANNOUNCEMENT



P.T. 34



Keywords:

  Vaccine 

  Bacteriology 



National Institute of Allergy and Infectious Diseases



The National Institute of Allergy and Infectious Diseases (NIAID),

Division of Microbiology and Infectious Diseases (DMID), is seeking

sources in developing countries that are capable of conducting one or

more randomized, controlled, double-blind field trials to demonstrate

the protective efficacy of new candidate pneumococcal vaccines against

vaccine-type pneumococcal infections in an infant population.



A pneumococcal vaccine containing capsular polysaccharide antigens of

23 serotypes is currently available and used in adults and high risk

children over two years of age.  Unfortunately, the vaccine is poorly

immunogenic in children below the age of two years and in other

high-risk groups.  To enhance the immunogenicity in these latter

populations, capsular polysaccharides have been coupled to carrier

proteins to form conjugate vaccines similar to the Hib conjugate

vaccines recently licensed and now part of the routine infant

vaccination schedule in many countries worldwide.



Because Streptococcus pneumoniae is a primary etiological agent of

pneumonia and contributes significantly to the development of

bacteremia and sepsis among young children in developing countries, it

is very important to test the safety and efficacy of these new

candidate pneumococcal vaccines in this setting.  In selecting a site,

it will be essential that information be available on the epidemiology

of pneumococcal disease especially with regard to the etiology of

pneumonia in young children in addition to knowledge of the individual

serotypes causing disease among children with invasive infections.

Other important factors that will be considered in the site selection

process include:  (1) availability of a population from a developing or

intermediate country that is sufficiently large and stable to

facilitate enrollment and follow-up; (2) an existing EPI program with

a coverage greater than 75 percent; (3) the ability to demonstrate that

a sufficient number of cases of confirmed pneumococcal infection can be

detected to meet trial requirements; (4) an existing laboratory

infrastructure to conduct serologic assays and perform definitive

diagnostic tests for pneumonia; (5) the ability to collect both acute

and convalescent serum specimens from suspected cases; (6) the ability

to collect and store sterile site specimens and biological specimens,

including nasopharyngeal aspirates, before and after immunization and

during and after disease; (7) the capability to recruit a sufficient

number of infants to have a high probability that the lower limit of a

two-sided 95 percent confidence interval for absolute efficacy to

prevent pneumococcal bacteremia with a new pneumococcal candidate

vaccine compared to a control vaccine will be greater than 40 percent

if true VE is 80 percent.  The sample size should also take into

consideration drop-out rates and other local factors that might affect

the overall calculations; (8) efforts to ensure that the quality of the

data for use by vaccine manufacturers when submitting applications for

licensure will meet the standards established by the FDA; (9) an

adequate morbidity and mortality surveillance mechanism in place; (10)

good access to medical care and treatment; (11) the ability to

randomize by individual and ensure the vaccine assignment of those

enrolled; and (12) the ability to maintain surveillance for a period of

up to two years.



The proposed study will represent a joint collaborative effort among

the NIH, NIAID, the WHO, and USAID.  The purpose of this advertisement

is to determine if there are sources capable of conducting efficacy

trials with the primary emphasis on assessing the absolute efficacy of

new candidate pneumococcal vaccines compared to a control vaccine in

preventing invasive pneumococcal infections in infants.  Secondary aims

might include examining the general safety of the vaccine under

investigation, exploring serological correlates of protection among

immunized infants, and determining the effect of the vaccine on

nasopharyngeal colonization and overall mortality.



Interested parties should submit six copies of a capability statement

no later than September 30, 1994.  The statement should, at a minimum,

address each of the areas outlined above.



This Sources Sought Announcement is a request for information to assist

the NIAID in planning for future efficacy trials.  It may or may not

result in a solicitation; at this time, no funds are available for

these purposes.



INQUIRIES



Interested parties are encouraged to respond by September 30, 1994.

Respondents are invited to discuss additional terms or conditions with

NIAID by contacting:



David L. Klein, Ph.D.

Division of Microbiology & Infectious Diseases

National Institute of Allergy and Infectious Diseases

Solar Building, Room 3B03

6003 Executive Boulevard, MSC 7630

Bethesda, MD  20892-7630

Telephone:  (301) 496-5305

FAX:  (301) 496-8030



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