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Journal of Transmitted Diseases and Immunity
ISSN: 2573-0320
Page 60
Volume 4
May 10-11, 2018
Frankfurt, Germany
Immunology Research 2018
Tissue Science 2018
JOINT EVENT
2 2
n d
E d i t i o n o f I n t e r n a t i o n a l C o n f e r e n c e o n
Immunology and
Evolution of Infectious Diseases
&
1 2
t h
E d i t i o n o f I n t e r n a t i o n a l C o n f e r e n c e o n
Tissue Engineering and
Regenerative Medicine
Objectives:
Clinical studies have been running in Sweden and in
Europe for 22 years with CF-patients on Anti-pseudomonas IgY
(Anti-PA IgY) to prevent infections with
Pseudomonas aeruginosa
(
PA
) to find out efficacy and adverse events. The promising results
gave Anti-PA IgY an Orphan Drug Designation in 2016.
Studies:
Phase II study was conducted during 1995 -2002: Two
groups with intermittently PA-infected patients: one group got
Anti-PA IgY, the other group was without IgY. Microbiologists
did not know from which group the analyses came from. A
prolonged study in Sweden continued 2002-2011. Pregnancy:
Two CF women, whereof one twice, were on Anti-PA IgY during
pregnancies. Transplanted: One boy transplanted 12 years ago
due to infections w.
PA
and Atyp.Mycobact. Phase III study 2002
-2017: A multicenter study from nine European countries.
Results:
Phase II: Group with Anti-PA IgY: 2.35 positive
PA
cultures/100 months; Untreated group: 7 positive
PA
/100
months. The duration from first to second colonization with PA
was significantly prolonged for the treated versus the control
group (Kaplan-Meier p=0.015). The time from first
PA
infection
until chronic infection occurred was prolonged in the Anti-PA IgY
treated group. The time until
PA
was transformed to the severe
mucoid form was prolonged. Lung function and BMI were well
preserved. Prolonged group: similar effects as those in the
first study. Three pregnancies have been carried out well and
gave birth to three healthy babies. Transplanted pat.: No new
pseudomonas or atypical mycobacterium after transplantation.
The few infections in the treated group minimized the need for
antibiotics. Phase III: The study was finished in June 2017. Totally
144 countable patients had been included. The results will be
ready in spring 2018. All patients have gargledmore than 250.000
times and no adverse events have been reported.
Discussion:
Anti-PA IgY has shown good results both in efficiency
and absence of adverse events. It reduces the use of antibiotics
and thus also the risk of resistant bacteria. Gargling is convenient
to use. Treatment is cost effective. Cost for Anti-PA IgY is much
less than the costs for antibiotics. The costs for days of illness
and for hospitalization will be much lower.
Conclusion:
Hopefully the now running double-blind, randomized
phase III study will give results as expected and Anti-PA IgY might
be registered and physicians will be able to give anti-PA IgY to all
eligible CF patients.
Biography
Hans Kollberg is Professor emeritus, Pediatrics, Children´s University Hos-
pital, Uppsala. He has a Specialization in Pediatrics from Swedish Medical
Board 1966. He holds a Medical Doctors Degree (MD) in Pediatrics from
Uppsala University, Sweden 1961. He started his career as Staff physician
(1959-1966), Resident Good Samaritan Hospital, Phoenix, Arizona (1966-
1967). He extended his service as a Director of the CF Center, University
Hospital, Uppsala and Umea in 1968-1982 and 1985-1999. He was pro-
fessor at the University of Kuwait 1982-1985. He has been a recipient of
many awards and grants. He is the Founder of the Swedish Cystic Fibrosis
Association, 1969. His research experience includes various programs, con-
tributions and participation in different countries for diverse fields of study.
His research interests as a Research Scholar reflect in his wide range of
publications in various national and international journals.
hans.kollberg@kbh.uu.seMore than 22 years of clinical studies on anti-pseudomonas
IgY to cystic fibrosis patients
Hans Kollberg
Uppsala University, Sweden
Hans Kollberg, J Transm Dis Immun 2018, Volume 2
DOI: 10.21767/2573-0320-C2-006